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PROTOCOL
Year : 2022  |  Volume : 6  |  Issue : 1  |  Page : 25-30

The efficacy and safety of Kantakaryavaleha and Eladi Gutika in the management of mild stable bronchial asthma (Tamaka Shwasa): study protocol for a multicenter, prospective, single-arm, open label, clinical study


Central Council for Research in Ayurvedic Sciences, Janakpuri, New Delhi, India

Date of Submission08-Feb-2022
Date of Acceptance21-Apr-2022
Date of Web Publication04-Aug-2022

Correspondence Address:
Dr. Bhagwan S Sharma
Central Council for Research in Ayurvedic Sciences, Janakpuri, New Delhi
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/jras.jras_26_22

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  Abstract 

BACKGROUND: Although Ayurveda medicine is used to manage bronchial asthma, available evidence relating to its efficacy needs to be generated. To scientifically evaluate the efficacy and safety of Ayurveda interventions, Kantakaryavaleha and Eladi Gutika, a multicenter, prospective, single-arm, open-label clinical study on mild stable bronchial asthma (Tamaka Shwasa) will be initiated. MATERIALS AND METHODS: 90 patients (45 in each center) with mild stable bronchial asthma will be enrolled based on inclusion and exclusion criteria. All the patients will be treated with Ayurveda medicines, i.e., Kantakaryavaleha 10 g, orally, twice daily with lukewarm water and tablet Eladi Gutika, 1 g thrice daily, orally. The intervention period will be 12 weeks and each participant will be followed up for 2 more weeks post intervention period. The primary outcomes will be measured assessing the change in the Asthma Control Questionnaire and the frequency of need for control medication before and after the trial intervention. The secondary outcomes will be measured by comparing the changes in clinical signs and symptoms of Tamaka Shwasa as per the Ayurveda classical text, changes in forced expiratory volume (FEV1), and biomarkers such as serum C-reactive protein (CRP), and IgE. TRIAL REGISTRATION: The trial has been registered at the Clinical Trials Registry-India (CTRI); the registration number for this trial is CTRI/2018/06/014425.

Keywords: Bronchial asthma, Eladi Gutika, Kantakaryavaleha, Tamaka Shwasa


How to cite this article:
Sharma BS, Mahajon B, Chincholikar MB, Rao BC, Srikanth N. The efficacy and safety of Kantakaryavaleha and Eladi Gutika in the management of mild stable bronchial asthma (Tamaka Shwasa): study protocol for a multicenter, prospective, single-arm, open label, clinical study. J Res Ayurvedic Sci 2022;6:25-30

How to cite this URL:
Sharma BS, Mahajon B, Chincholikar MB, Rao BC, Srikanth N. The efficacy and safety of Kantakaryavaleha and Eladi Gutika in the management of mild stable bronchial asthma (Tamaka Shwasa): study protocol for a multicenter, prospective, single-arm, open label, clinical study. J Res Ayurvedic Sci [serial online] 2022 [cited 2022 Aug 18];6:25-30. Available from: http://www.jrasccras.com/text.asp?2022/6/1/25/353407




  Introduction Top


Background and rationale

Tamaka Shwasa (bronchial asthma) is one of the pathological conditions mentioned under five types of Shwasa Roga (respiratory disorders) in Ayurveda.[1],[2] It is an independent disease with its own etiology, pathophysiology, and management. According to the classics of Ayurveda, Tamaka Shwasa is a Yapya Vyadhi (a disease of the chronic nature and difficult to cure).[3] Though it is a disorder of Pranavaha Srotas (respiratory system), other Srotas (channels) might also be involved.[4] The analogous disease entity in contemporary medical science to Tamaka Shwasa is bronchial asthma. Bronchial asthma is a chronic inflammatory disease of the airways characterized by bronchial hyperreactivity and a variable degree of airway obstruction.[5] Genetic predisposition toward the production of IgE antibodies in response to pollen, house dust mites, fungi, or animal-derived proteins, etc., are the most important risk factors for bronchial asthma.[6] This disease is commonly diagnosed based on the clinical history, physical examination, and pulmonary function tests, including reversibility testing and the measurement of bronchial reactivity. According to recent data, bronchial asthma afflicts about 10% of children and 5% of adult and about 300 million people worldwide. The World Health Organization (WHO) estimates the number of disability-adjusted life years (DALYs) lost to asthma at 15 million per year, corresponding to 1% of the global loss of DALYs due to illness.[6],[7] The Global Initiative for Asthma (GINA) in the 2006 update proposed a new classification of asthma, based on the level of control rather than the previous classification based on the severity of the underlying disease process.[8] Long-term treatment with inhaled corticosteroids is the basis of asthma treatment, alongside preventive measures and patient education. Several medicines are available, but they have many serious side effects. None of the available treatments are effective in providing a complete cure for this disease. Thus it was proposed that the asthma treatment goal, regardless of a patient’s asthma severity, should lead to the achievement of complete disease control. In addition, the prevention of future risks should also be intended.[9],[10] The goal of management is to control the symptoms of the disease effectively and in a lasting fashion.[11] Therefore, there is a need to search for a new therapeutic agent with no or minimal side effects.[11],[12] Ayurveda in its texts has lots of herbomineral compounds, which can fill up this gap. The classics of Ayurveda contribute several modalities of treatment for Tamaka Shwasa. Among all treatment modalities, herbal combinations are well-accepted, mostly easily available, and also effective in asthma control.[13] Thus, based on textual and clinical experience, classical Ayurveda formulations, Kantakaryavaleha and Eladi Gutika are selected for clinical trial to study their role in disease control among patients with bronchial asthma.

Study objective

To evaluate the safety and efficacy of classical Ayurveda formulations Kantakaryavaleha and Eladi Gutika in the management of mild stable bronchial asthma (Tamaka Shwasa).

Trial design

This will be a multicenter, prospective, single-arm, open-label, clinical study.


  Materials and Methods Top


Study setting

The study will be conducted at Central Ayurveda Research Institute (CARI), Patiala, Punjab, and Regional Ayurveda Research Institute (RARI), Vijayawada.

Eligibility criteria

Inclusion criteria

Following are the inclusion criteria: Patients of either sex with age between 18 and 60 years, diagnosed with mild predominant or persistent stable bronchial asthma (Tamaka Shwasa) (as per GINA guidelines); forced expiratory volume (FEV1) >80% of the predicted value; and patients’ willingness to participate and sign written consent.

Exclusion criteria

Following are the exclusion criteria: patients with diabetes mellitus, chronic obstructive pulmonary disorder, malignancy, etc.; patients with unstable cardiovascular disease; patients suffering from other major systemic illness that may influence the study; patients with liver function tests, aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >2 times upper normal limit, or serum creatinine more than the upper limit of normal value; pregnant or lactating women will be excluded from the study.

Interventions

All the participants will be treated with traditional Ayurveda medicine, i.e., Kantakaryavaleha,[14] 10 g, orally, twice daily with lukewarm water and tablet Eladi Gutika,[15] 1 g thrice daily, orally [Table 1]. Quality assured trial interventions would be procured from GMP certified pharmacies. To alleviate emergency (if any occurred), the use of rescue medication will be done. The same need to be documented in an appropriate column in the case report form (CRF).
Table 1: Detailed posology of the selected interventions

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Outcomes

Primary outcome measures

Change in score of Asthma Control Questionnaire (ACQ) and dependency on standard of care in the form of Asthma control medication.

Secondary outcome measures

Change in FEV1, Serum C Reactive Protein and IgE; frequency of rescue medication and incidence of adverse events.

Participant timeline

A total of 90 participants will be enrolled at the two study centers. All the participants will undergo a 12-week treatment and a 2-week follow-up period. A washout period of 2 weeks will be provided to the participants who are already taking any traditional medicine other than standard of care. Time-line of the study events is mentioned in [Table 2].
Table 2: Participant timeline

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Sample size

The sample size was calculated based on the primary outcomes, which was the change in Asthma Control Questionnaire (ACQ) from baseline to week 12. Based on the previous studies, anticipating a change of 1.05 in ACQ, and assuming a standard deviation of 2.25 points with 95% confidence level (α = 0.05 and 80% power, the sample size is 36. Anticipating a drop out of 20%, the sample size was estimated as 43 (36.04 + 7.20 = 43.24) and rounded off as 45 at each centre.

Enrollment of participants

The patients in OPDs of the study centers and medical camps organized by the study centers will be sensitized about this study. The willing patients will be screened for eligibility. After obtaining the informed written consent from the eligible participants, they will be enrolled in the study who will undergo the baseline assessments.

Data collection, management, and analysis

The plan for data collection is depicted in [Figure 1]. All information pertaining to this study shall be properly documented, carefully handled, and meticulously stored in order to ensure its accurate interpretation and verification. Statistical analysis of the data collected shall be done by the Biostatistics department of CCRAS. The records and data collected during the study will be stored in password-protected folders on a secure set up and also in external data storage devices. Only the investigator will have access to the stored data.
Figure 1: Study flowchart

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Statistical methods

Clinical symptoms, subjective parameters and laboratory parameters will be subjected to univariate and multivariate analysis using statistical package for social sciences SPSS 15.0 version with appropriate statistical methods.

Data Monitoring

Periodical monitoring by the experts at headquarters will ensure Data safety during the trial.

Harms (AE/ADR)

Any AE or ADR observed during the treatment period or during follow-up visits will be clearly documented, and its appropriate and timely management will be done. The investigator will report the same to the Ethics committee and the funding organization at the earliest.

Research ethics approval

The trial will be conducted in accordance with ethical principles that have their origin in the Declaration of Helsinki for biomedical research and ICMR National Ethical Guidelines for Biomedical Research involving Human Participants (2017) and that are consistent with Indian/International Council for Harmonisation GCP guidelines/GCP guidelines for Clinical trials in Ayurveda, Siddha, Unani Medicine (2013). Prior to the commencement of the trial, the protocol, the participant information sheet, and the consent form will be submitted to the Institutional Ethics Committee. The written approval of the same shall be obtained from the IEC. Protocol amendments if any, will also be submitted to the IEC for approval. Trial is already registered under Clinical Trials Registry-India CTRI vide the registration number CTRI/2018/06/014425.

Consent

Patient information sheet and consent form

Prior to any trial-related activity, the investigator will give the patient verbal and written information about the trial in a form the participant can read and understand. The investigator will ensure that the participant is fully informed about the aims, procedures, discomforts, and expected benefits of the trial. It shall be emphasized that the participation is voluntary and participants have the right to opt out of the trial at any time without any prejudice. A voluntary, signed witnessed informed consent shall be obtained from the participant prior to any clinical trial-related procedures (Details are provided in supplementary material).

Confidentiality

All information will be kept confidential and medical records may be inspected by the sponsors for the purpose of analyzing the results. They may also be looked at by members of Institutional Ethics Committee. Participants' identity and personal details will be kept strictly confidential.


  Discussion Top


Tamaka Shwasa is a chronic inflammatory condition of the lung airways resulting in episodic airflow obstruction. This disease is more predominant in children and the aged population. The parallel disease entity in contemporary medical science to this disorder is bronchial asthma.[16] Bronchial asthma is a significant health issue, especially in developing countries like India and is responsible for significant morbidity. It is a chronic inflammatory disorder of the airways characterized by bronchial hyperresponsiveness and variable airflow obstruction that is often reversible either spontaneously or with treatment.[17] According to Acharya Sushruta, when the natural association of Prana Vayu (one of the five subtypes of Vata that is seated in head) is hindered and it is coupled with Kapha, afterward it leads to the origin of Shwasa Roga (respiratory disorders).[18] The genesis of respiratory disorders first involves only vitiation of Vata dosha all over the body. This vitiated Vata, which is in Urahasthana (chest/thorax), in turn creates Rukshata (~roughness), Sankocha (~constriction), and Kharata (~roughness) in Pranavaha Srotas (respiratory system). Vitiated Vata affects the normal Kapha in Urahasthana (chest/thorax), which results in Vilomata (moves in the wrong direction) of Prana Vayu through the obstruction to its natural movement by Kapha. In the other way, both Vata and Kapha get vitiated independently along with the production of Amavisha (symptoms of Amavisha), which eventually contributes to the manifestation of respiratory disorders.[19] In the present study, Kantakaryavaleha and Eladi Gutika have been selected for the management of mild stable bronchial asthma. However, a large number of medicines in the form of Avaleha (semi-solid preparation) have been described for the treatment of respiratory disorders as these have Brimhana (nourishment) property, which is important to prevent the pathogenesis of this disease.[20],[21],[22] The selected formulation Kantakaryavaleha possesses several potential herbal ingredients that are efficient to combat the pathophysiology of mild stable bronchial asthma (Tamaka Shwasa). Along with Tamaka Shwasa, the formulation also acts in pacifying symptoms of other respiratory diseases such as Hikka (hiccough), Kasa (cough), and Shula (pain).[14] The other drug Eladi Gutika is also beneficial in management of Chardi (vomiting), Hikka (hiccough), Kasa (cough/tussis), Bhrama (vertigo), Murccha (fainting), Raktapitta (bleeding disorders), Rakta Nishthivana (hematemesis), Jvara (fever), Trishna (excessive thirst), Aruchi (anorexia), Parshwa Shula (flank pain), Shosha (emaciation), Pliharoga (spleen disorders), Amavata (rheumatism due to Ama/rheumatoid arthritis), Svarabheda (hoarseness of voice), and Shukra Kshaya (diminution of semen).[15] The protocol was designed for assessment of clinical outcome of Kantakaryavaleha and Eladi Gutika in the treatment of Tamaka Shwasa (mild stable bronchial asthma). If found effective, the selected drug, i.e., Kantakaryavaleha and Eladi Gutika can be studied for evaluation of their efficacy through randomized controlled trials on larger sample size.

Financial support and sponsorship

This trial is supported financially by the Central Council for Research in Ayurvedic Sciences New Delhi, an autonomous body under Ministry of Ayush, Government of India.

Conflicts of interest

There are no conflicts of interest.



 
  References Top

1.
Agnivesha, Charaka, Dridhabala. Chikitsa Sthana, Hikka Shwas Chikitsa Adhyaya 17/17. In: Acharya JT, editor. Charaka Samhita. Varanasi: Chaukhambha Orientalia; 2011. p. 533.  Back to cited text no. 1
    
2.
Vagbhata. Nidana Sthana, Shwas Nidana Adhyaya 4/2. In: Paradkar H, editor. Ashtanga Hrudaya. 9th ed. Varanasi: Chaukhambha Orientalia; 2005. p. 472.  Back to cited text no. 2
    
3.
Agnivesha, Charaka, Dridhabala. Chikitsa Sthana, Hikka Shwas Chikitsa Adhyaya 17/62. In: Acharya JT, editor. Charaka Samhita. Varanasi: Chaukhambha Orientalia; 2011. p. 535.  Back to cited text no. 3
    
4.
Agnivesha, Charaka, Dridhabala. Chikitsa Sthana, Hikka Shwas Chikitsa Adhyaya, 17/45. In: Charaka Samhita, commentary by Chakrapanidatta. Reprint ed. Varanasi: Chaukhambha Orientalia; 2011. p. 535.  Back to cited text no. 4
    
5.
Behrman RE, Kliegman RM, Jenson HB Nelson Textbook of Pediatrics. 17th ed. Philadelphia, PA: Saunders, An Imprint of Elsevier USA; 2003. p. 761.  Back to cited text no. 5
    
6.
Ukena D, Fishman L, Niebling WB Bronchial asthma: Diagnosis and long-term treatment in adults. Dtsch Arztebl Int 2008;105:385-94.  Back to cited text no. 6
    
7.
Zainab R, Akram M, Daniyal M, Riaz M Awareness and current therapeutics of asthma. Dose Response 2019;17: 1559325819870900.  Back to cited text no. 7
    
8.
GEMA. Spanish guidelines for diagnosis and asthma management. J Invest Alergol Clin Immunol 2010;20:S1.  Back to cited text no. 8
    
9.
Bateman ED, Reddel HK, Eriksson G, Peterson S, Ostlund O, Sears MR, et al. Overall asthma control: The relationship between current control and future risk. J Allergy Clin Immunol 2010;125:600-8, 608.e1-608.e6.  Back to cited text no. 9
    
10.
Olaguibel JM, Quirce S, Juliá B, Fernández C, Fortuna AM, Molina J, et al; MAGIC Study Group. Measurement of asthma control according to global initiative for asthma guidelines: A comparison with the asthma control questionnaire. Respir Res 2012;13:50.  Back to cited text no. 10
    
11.
Kumar GS, Roy G, Subitha L, Sahu SK Prevalence of bronchial asthma and its associated factors among school children in urban Puducherry, India. J Nat Sci Biol Med 2014;5:59-62.  Back to cited text no. 11
    
12.
Bush A Pathophysiological mechanisms of asthma. Front Pediatr 2019;7:68.  Back to cited text no. 12
    
13.
Panda AK, Doddanagali SR Clinical efficacy of herbal Padmapatradi yoga in Bronchial Asthma (Tamaka Swasa). J Ayurveda Integr Med 2011;2:85-90.  Back to cited text no. 13
    
14.
Anonymous. The Ayurvedic Formulary of India (AFI) (Ministry of Health and Family Welfare, Govt. of India, New Delhi) Part I. 2nd ed. Delhi: The Controller of Publications; 2003. p. 34.  Back to cited text no. 14
    
15.
Anonymous. The Ayurvedic Formulary of India (AFI) (Ministry of Health and Family Welfare, Govt. of India, New Delhi) Part I. 2nd ed. Delhi: The Controller of Publications; 2003. p. 182.  Back to cited text no. 15
    
16.
Dubey AK, Rajagopala S, Patel KS Comparative clinical efficacy of Ashtangavaleha and Vyaghreehareetakee Avaleha on Tamaka Shwasa (bronchial asthma) in children. Ayu 2014;35:384-90.  Back to cited text no. 16
    
17.
Agarwal R, Dhooria S, Aggarwal AN, Maturu VN, Sehgal IS, Muthu V, et al. Guidelines for diagnosis and management of bronchial asthma: Joint ICS/NCCP (I) recommendations. Lung India 2015;32:S3-S42.  Back to cited text no. 17
    
18.
Acharya JT, editor. Sushruta Samhita. Nibandha Sangraha and Nyaya Candrika commentary by Dalhana. Varanasi: Chaukhamba Surbharati Prakashan; 2008. p. 761.  Back to cited text no. 18
    
19.
Gupta A, Prajapati PK Effect of different Avaleha in the management of Tamaka Shwasa (bronchial asthma). Ayu 2011;32:427-31.  Back to cited text no. 19
    
20.
Agnivesha, Charaka, Dridhabala. Chikitsa Sthana, Hikka Shwasa Chikitsa Adhyaya 17/149-150. In Acharya JT, editor. Charaka Samhita. Varanasi: Chaukhambha Sanskrit Samsthan; 2001. p. 542.  Back to cited text no. 20
    
21.
Shastri P, editor. Madhyam khanda. In: Sharangadhara Samhita, Dipika commentary by Adhamalla and Gudarthadipika commentary by Kashiram. 5th ed. 05-07. Vol. 8. Varanasi: Choukhambha Orientalia; 2002. p. 207.  Back to cited text no. 21
    
22.
Agnivesha, Charaka, Dridhabala. Chikitsa Sthana, Hikka Shwasa Chikitsa Adhyaya 17/89. In Acharya JT, editor. Charaka Samhita. Varanasi: Chaukhambha Sanskrit Samsthan; 2001. p. 539.  Back to cited text no. 22
    


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    Tables

  [Table 1], [Table 2]



 

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