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 Table of Contents  
PROTOCOL
Year : 2021  |  Volume : 5  |  Issue : 3  |  Page : 131-138

Clinical evaluation of the efficacy of Shadbindu Taila and Chitraka Haritaki in the management of chronic rhinosinusitis: Protocol for a prospective, open-label multicenter single-arm trial


1 Central Ayurveda Research Institute (CARI), Central Council for Research in Ayurvedic Sciences (CCRAS), New Delhi, India
2 Central Ayurveda Research Institute (CARI), Central Council for Research in Ayurvedic Sciences (CCRAS), Patiala, India
3 Central Council for Research in Ayurvedic Sciences (CCRAS), New Delhi, India

Date of Submission12-Aug-2021
Date of Acceptance12-Jan-2022
Date of Web Publication22-Mar-2022

Correspondence Address:
Dr. Shweta Mata
Central Ayurveda Research Institute (CARI), Central Council for Research in Ayurvedic Sciences (CCRAS), New Delhi.
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/jras.jras_43_21

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  Abstract 

BACKGROUND: The disease Pinasa (chronic rhinosinusitis disease) is a chronic nasal disease, which affects nasal canal and paranasal sinuses and the symptoms of this disease are similar to that of chronic rhinosinusitis. In Ayurvedic classics, the internal administration of Chitraka Haritaki Avaleha (CHA) and nasal instillation of Shadbindu Taila (SBT) are mentioned for the management of Pinasa. In view of the literary indication, the present work was carried out with the objective to evaluate the clinical efficacy and safety of CHA and SBT in the management of chronic rhinosinusitis. MATERIALS AND METHODS: A multicenter, single-arm, open-label clinical trial was proposed for the assessment of therapeutic efficacy of oral administration of CHA and nasal instillation of SBT. A total of 60 patients with chronic rhinosinusitis from Central Ayurveda Research Institute (CARI), New Delhi and CARI, Patiala were enrolled in this study. SBT Nasya (nasal drop to be given for three sittings, 7 days in each, with the interval of 7 days between each sitting) and CHA (6 g, twice daily after food) in the form of Avaleha (semisolid confection) were given to all participants for 42 days and the follow-up period was 28 days. The primary outcome was to assess change in SNOT (Sino-Nasal Outcome Test) scores. The secondary outcome was to assess change in RSDI (Rhinosinusitis Disability Index) scores and change in Lund-Mackay scores of computed tomography (CT) scan of paranasal sinuses. CONCLUSION: The effect of CHA and SBT nasal drop in treatment of Pinasa with special reference to chronic rhinosinusitis may provide an evidence-based complementary therapeutic approach for the management of the said condition.

Keywords: Nasal drop, Chitraka Haritaki, chronic rhinosinusitis, Pinasa, Shadbindu Taila


How to cite this article:
Mata S, Singh H, Makhija D, Yadav B, Singhal R, Chandrasekhara Rao B, Shivshankar R, Gupta B, Srikanth N. Clinical evaluation of the efficacy of Shadbindu Taila and Chitraka Haritaki in the management of chronic rhinosinusitis: Protocol for a prospective, open-label multicenter single-arm trial. J Res Ayurvedic Sci 2021;5:131-8

How to cite this URL:
Mata S, Singh H, Makhija D, Yadav B, Singhal R, Chandrasekhara Rao B, Shivshankar R, Gupta B, Srikanth N. Clinical evaluation of the efficacy of Shadbindu Taila and Chitraka Haritaki in the management of chronic rhinosinusitis: Protocol for a prospective, open-label multicenter single-arm trial. J Res Ayurvedic Sci [serial online] 2021 [cited 2022 Jun 26];5:131-8. Available from: http://www.jrasccras.com/text.asp?2021/5/3/131/340290




  Background and Rationale Top


The disease Pinasa is a chronic nasal disease, which affects the nasal canal and paranasal sinuses. According to Bhavaprakash, the specific symptoms of Pinasa include nasal obstruction and burning sensations in the nostrils, as well as dryness and deposit of filthy slimy mucus in their passages, temporarily deadening the senses of smell and taste.[1] This definition is also mentioned by Acharya Sushrut[2] and Acharya Charak[3] in Apinasa disease and the symptoms may be correlated with chronic rhinosinusitis in contemporary biomedicine. Rhinosinusitis is an inflammation of the mucous membranes of the sinuses and paranasal sinuses. According to the American Academy of Allergy, Asthma and Immunology (AAAAI),[4] chronic sinusitis is one of the most common chronic illnesses in people younger than 45 years of age in the United States. Chronic sinusitis lasts longer than 12 weeks and it is not a simple bacterial infection but represents a multifactorial inflammatory disorder.[5] Use of antibiotics is the preferred treatment in chronic rhinosinusitis; however, surgery may be required in case of unsatisfactory relief with medicines.[6] Moreover, the symptomatic treatment generally results only in temporary relief and thus the recurrence rate of rhinosinusitis is very high.[7]

The available clinical evidences indicate that Ayurveda has promising results in the treatment of chronic rhinosinusitis. Few published studies proving the efficacy of Ayurveda interventions such as Vidanga Taila Nasya,[8]Pradhaman Nasya and Trayodashang Kwath,[9]Trikatu Taila Nasya,[10]Anu Taila Nasya and Vyaghriharitaki Avaleha,[11]Nimbadi Guggulu and Ardhanarishvara Rasa Nasya,[12] and Varunadi Ghrita[13] are available on various databases. However, no any study is available on Chitraka Haritaki Avaleha (CHA) and Shadbindu Taila (SBT) for chronic rhinosinusitis to date. The Ayurvedic approach to treating rhinosinusitis focuses on strengthening the physiological processes that help aid the body in mounting an active defense against the disease. This is accomplished by the use of a variety of formulations, in different routes, such as oral or nasal. CHA is mentioned in Nasarogadhikara Chikitsa (treatment of nasal diseases) in Chakradatta.[14] SBT is another medication described in Bhaishajyaratnavali Shirorogachikitsa[15] (treatment of diseases of head) for the management of almost all Urdhajatrugata Rogas (diseases above the neck). Based on classical indications, it can be interpreted that CHA and SBT need to be studied for the management of rhinosinusitis. In view of the need, the present work is undertaken. The findings of this study could be used to develop an evidence-based additional treatment approach for Pinasa. Details on the overall trial design and approach are included in this protocol.

Primary objective

To assess the clinical efficacy of CHA and SBT Nasya in the treatment of chronic rhinosinusitis.

Secondary objectives

Evaluation of the safety of CHA and SBT Nasya in the management of chronic rhinosinusitis.

Trial design

This clinical study is designed as a multicenter, single-arm prospective trial [Figure 1].
Figure 1: Study procedure

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  Materials and Methods Top


Participants, interventions, and outcomes

In this study, 60 patients with chronic rhinosinusitis were studied in two centers of the Central Council for Research in Ayurvedic Sciences (CCRAS), Ministry of AYUSH, Government of India, New Delhi.

Study settings

The study was conducted at Central Ayurveda Research Institute (CARI), New Delhi and CARI, Patiala. The study consists of three components, that is, an initial screening, a treatment period, and a follow-up period. In the initial screening, patients with a history of chronic sinusitis were recruited via an ENT clinic for physical examination and inclusion assessment. Laboratory investigations and computed tomography (CT) scan Para Nasal Sinus (PNS) were done in the screening stage.

Eligibility criteria

Inclusion criteria

Patients of either sex with age between 18 and 60 years and known case of chronic rhinosinusitis as per the criteria of the American Academy of Otolaryngology – Head and Neck Surgery Foundation (AAO-HNS) were included in the study. The symptoms according to AAO-HNS includes presence of two or more of the signs and symptoms such as mucopurulent drainage (anterior, posterior, or both)/nasal obstruction (congestion)/facial pain–pressure–fullness, or decreased sense of smell and inflammation for 12 weeks or more. The symptoms were documented by one or more of the findings such as purulent (not clear) mucus or edema in the middle meatus or anterior ethmoid region, polyps in the nasal cavity or the middle meatus, and/or radiographic imaging showing inflammation of the paranasal sinuses. Patients who fulfilled the criteria and were willing to give written informed consent for the participation were included in the study.

Exclusion criteria

Patients below 18 and above 60 years of age, with a history of chronic nasal or upper respiratory tract symptoms or disorders other than sinusitis, patients with tonsillitis/adenoids, patients who were on treatment with H1 antihistamine medication, non-steroidal analgesics or those taking medications such as corticosteroids nasal drops, leukotriene antagonists, and nasal vasoconstrictors in the last 15 days were excluded from the study. Patients with uncontrolled diabetes mellitus (blood sugar fasting >250 mg/dL) or poorly controlled hypertension (≥160/100 mm Hg), patients suffering from major systemic illnesses such as rheumatoid arthritis, tuberculosis, psycho-neuro-endocrinal disorders necessitating long-term drug treatment, and patients who had a past history of atrial fibrillation, acute coronary syndrome, myocardial infarction, and stroke or severe arrhythmia in the last 6 months were excluded from the study. Symptomatic patients with clinical evidence of heart failure, patients with concurrent serious hepatic disorder (defined as aspartate aminotransferase [AST] and/or alanine aminotransferase [ALT], total bilirubin, alkaline phosphatase [ALP] > 2 times the upper normal limit) or renal disorders (defined as serum creatinine > upper limit of the normal level) were also excluded from the study. Also, patients who were alcoholics and/or drug abusers, pregnant women and lactating mothers, and those who had participated in any other clinical trial during the past 6 months, and any other condition which the investigator thinks may jeopardize the study were excluded from the study.

Interventions

SBT Nasya (nasal drop to be given for three sittings, 7 days in each, with the interval of 7 days between each sitting) and CHA (6 g, twice daily after food) in the form of Avaleha (semisolid confection) were given to all participants. Total duration of treatment was 42 days. Details about ingredients of intervention are given in [Table 1] and [Table 2], whereas posology details are given in [Table 3].
Table 1: Ingredients of Shadbindu Taila

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Table 2: Ingredients of Chitraka Haritaki Avaleha

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Table 3: Detail posology of the selected interventions

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Concomitant and rescue medication

The investigator will record any medication(s) he/she may prescribe to alleviate their ailments. Only the investigator will be able to withdraw a participant from the experiment, and he or she will be required to provide a comprehensive rationale as well as a line for continued care if necessary. Within two working days, the sponsor and the ethics committee will be intimated along with the detail recorded by the investigator. The investigator will record any medication(s) he/she may prescribe to alleviate their ailments. Only the investigator will be able to withdraw a participant from the experiment, and he or she will be required to provide a comprehensive rationale as well as a line for continued care if necessary.

Outcome measures

Primary outcome measures

Change in SNOT (Sino-Nasal Outcome Test) scores.

Secondary outcome measures

Change in RSDI (Rhinosinusitis Disability Index) scores and Change in Lund-Mackay scores[16] of CT scan PNS.

Study timeline

Informed consent, eligibility evaluation, all laboratory investigations, and CT scan PNS will be done in screening. A 15-day washout period was kept for participants who were on other medications such as corticosteroids nasal drops, leukotriene antagonists, and nasal vasoconstrictors. General information such as personal identification and demographic profile, medical history, general, physical and systemic examination, assessment through Ayurvedic parameters and ENT (ear, nose throat) examination, RSDI, and SNOT score will be done during baseline. During treatment, on the 14th and 28th days, drugs and drug compliance report forms were distributed, drug compliance report forms were collected, an ENT examination was performed, a clinical assessment was performed, RSDI and SNOT score were performed, and instructions to visit after 14 days were given. Similar examinations and lab investigations were done on the 42nd day. Follow-up was done on the 70th day. ENT examination and clinical assessment was done during the follow-up period. The total number of visits was 5 for assessment. The detail of the participant timeline is provided in [Table 4].
Table 4: Gantt chart of participant timeline

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Sample size

Assuming a reduction in SNOT-22 composite score by 65% after treatment, the sample size was calculated considering a 95% confidence interval and 80% power. The sample size of 54 was calculated based on the formula 4PQ/L2, where P was 65%, Q was 35%, and L (allowable error was 0.13, 20% of P). Adding a dropout rate of 10%, the esteemed sample size became 60.

Data collection, management, and analysis

The data collection will include all information in the case report forms (CRFs). All participants will be assigned an enrollment number, which will be used on CRFs and on electronic databases. Consent forms and CRFs will be stored in locked cup-boards and electronic databases will be kept password protected. The data will be entered using the double-entry method for accuracy. All data will be accessible to the PI and Co-I during and after the study has completed, and will be available to sponsor and monitors as required. Data will be stored for 5 years before being destroyed. In case of dropout, 10% data will be inserted through imputation technique. Proper documentation will be done to ensure its accurate interpretation and verification. Analysis will be done by CCRAS statistical unit.

Drug compliance

If there is more than or equal to 80% compliance, the participant would be continued in the trial. The compliance will be assessed at each visit during the follow-up (i.e., 14th, 28th, and 42nd days) by counting the number of empty containers/bottles of provided medicines returned and by assessing the approximate quantity of Avaleha consumed by the patient.

Statistical methods

The continuous data collected on outcome measures viz. SNOT score, Rhinosinusitis Disability Index score, and Lund-MacKay score were presented as mean and standard deviation, and were analyzed using paired sample t test. The descriptive data on participants’ demographic profile and baseline characteristics were presented as number and percentages. Statistical analysis was done using Statistical Package for Social Sciences (SPSS) software program, version 15.0. The results were interpreted as significant (P < 0.05), highly significant (P < 0.01), very highly significant (P < 0.001), and insignificant (P > 0.05). The confidence interval was set at 95%.

Monitoring

The Data and Safety Monitoring Board (DSMB)of CCRAS monitored the project’s progress.

Harms: Adverse event or adverse drug reaction

Any adverse event or adverse drug reaction if observed during the treatment period or follow-up visits was recorded in structured formats for data capture and carefully documented and was managed appropriately and promptly. The principal investigator reports the event to the licensing authority (DCGI), sponsor, and Chairperson of the Institutional Ethics Committee (IEC) within 24 h of the occurrence of the serious adverse events (SAE).

Research ethics approval

This research protocol was reviewed and approved by the institutional Ethics Committee (IEC) of both trial centers.

Protocol amendments

IEC approval was taken before any deviations from the protocol, including unplanned changes to interventions, examinations, data collection, and method of analysis.

Patient information and consent form

Prior to trial initiation, the investigator provided verbal and written information about the trial in a way that the participant can read and understand. The aims, procedures, discomforts, and expected benefits of the trial were fully informed to the participant. It was ensured that participation is voluntary and participants have the right to choose out of the trial at any time without any prejudice. Signed informed consent was taken from all participants before the initiation of trial.

Confidentiality

All information of the participants were kept confidential. The medical records may be inspected by the sponsors for the purpose of analyzing the results. They may also be looked at by members of the Institutional Ethics Committee and by Regulatory authorities/Court to check that the study is being carried out correctly. However, participant’s name was not made public and any sensitive matter regarding state of health was kept confidential.

Dissemination

The findings will be disseminated to the public through presentations in conference and research paper publication open-access journals.


  Discussion Top


Respiratory tract infection or its complications are the major cause of hospital visits worldwide.[17] Repeated respiratory infection or its improper management during the acute stage can lead the disease to a chronic phase.[18] Paralysis of cilia and blockage of the sinus ostia may lead to the retention of discharge and the sinus becomes as a closed cavity with purulent discharge in the chronic phase.[19] Complications such as tonsillitis, pharyngitis, laryngitis, and otitis media are also common in this stage.[20] In the allopathy medical system, a wide range of antibiotics and decongestants are available.[21] However, these drugs have several limitations in treating such a chronic condition.[22] If conservative measures fail, Functional Endoscopic Sinus Surgery (FESS), Caldwell-Luc operation, and Howarth’s operation are the chief operative procedures performed to drain the sinus.[23] All these surgical procedures may result in complications such as bleeding, oro-antral fistula, infra-orbital anesthesia, and paresthesia.[24]

Medicated nasal drop (Shodhana Nasya) is one of the commonly used Ayurveda routes of drug administration for bio-purification through nasal route especially in diseases of ENT and head. Before Nasya, oleation and hot fomentation are performed to liquefy the channel obstructing cause (~Doshas), which later can be expelled out by Nasya. SBT was selected as it can help in curing the etiopathogenesis of disease chronic rhinosinusitis. According to Ayurveda perspectives, the digestion mechanism (~Agni), various body fluids/tissues (~Dhatus), the fundamental physiological factors (~Doshas), and the immunity of a person are involved in the manifestation of chronic diseases and hence the ultimate aim of the treatment is to correct all these factors. Impairment indigestive function may lead to formation of Ama, which is an incompletely digested form of various body fluids or can be correlated with ketone bodies.[25] This in turn can affect the process of absorption and assimilation and thereby decreases immunity and general health. Rasayana (rejuvenation) concept in the Ayurvedic system of medicine can prove as a major approach to treat immunity and age-related diseases. CHA is a formulation that acts on improving digestion mechanism as well as a Rasayana. Plumbago zeylanica Linn has the basic property to digest the Ama[26]Terminalia chebula Retz is known for Rasayana effect are the main ingredients.[27]Embelica officinalis Gaertn. and Tinospora cordifolia Miers. are also well-known drugs for rejuvenation and have a definite role to play in the maintenance and preservation of health.[28] Decoction being prepare from Dashamoola is known for anti-inflammatory and analgesic activity.[29] By keeping these aspects into consideration, CHA had been selected for the treatment protocol. The trial is designed with optimal transparency and nominal reporting bias to improve the standardization of data collection. Some studies have shown that SBT Nasya and CHA had some success in the treatment of chronic rhinosinusitis, but there are less evidence-based clinical research data on their combined use. This protocol has been designed according to the SPIRIT 2013 guidelines.


  Conclusion Top


The results of SBT Nasya and CHA administration are expected to have significant efficacy in providing relief in associated symptoms as well as in reducing the rate of recurrence of chronic rhinosinusitis. The protocol may also serve as a reference for the planning of similar clinical trials.

CTRI registration no.

This trial is registered with CTRI (Clinical Trials Registry of India) (Registration no. CTRI/2019/04/018509, dated April 9, 2019).

Financial support and sponsorship

This study was supported by the Central Council for Research in Ayurvedic Sciences (CCRAS), under Ministry of AYUSH, Govt. of India, New Delhi.

Conflicts of interest

There are no conflicts of interest.



 
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