|Year : 2022 | Volume
| Issue : 3 | Page : 101-108
A clinical study to evaluate the efficacy of Ayurvedic intervention in management of chronic bronchitis
Rinku Tomar, Babita Yadav, Harbans Singh, Amin Hetalben, Shruti Khanduri, Bhagwan Sahay Sharma, Rakesh Rana, Richa Singhal, Bhogavalli Chandrasekhararao, Narayanam Srikanth, Kartar Singh Dhiman
Central Council for Research in Ayurvedic Sciences (CCRAS), Ministry of AYUSH, Govt. of India, New Delhi, India
|Date of Submission||06-Jan-2022|
|Date of Acceptance||21-Sep-2022|
|Date of Web Publication||01-Nov-2022|
Dr. Amin Hetalben
Central Council for Research in Ayurvedic Sciences (CCRAS), Ministry of AYUSH, Govt. of India, D-Block, Janak Puri, New Delhi 110058
Source of Support: None, Conflict of Interest: None
INTRODUCTION: Talisadi Churna (TC) is an Ayurveda formulation indicated in managing Kaphaja Kasa. The symptoms of Kaphaja Kasa, narrated in the Ayurveda classical texts, resembles with chronic bronchitis (CB). This open-label, single-arm, prospective study was planned to evaluate the efficacy of TC in the management of CB. MATERIALS AND METHODS: Seventy-five patients who fulfilled the inclusion criteria for CB were enrolled at Central Ayurveda Research Institute for Respiratory Disorders, Patiala. They were treated by oral administration of TC 3 gm thrice a day for 12 weeks with a post-treatment follow-up after four weeks. The results were assessed by change in Leicester Cough Questionnaire (LCQ) Score, episodes of acute exacerbation, change in St. George’s Respiratory Questionnaire (SGRQ) Score for Quality-of-life, Functional/Exercise capacity [change in peak expiratory flow rate (PEFR) and FEV1%] and occurrence of adverse events. RESULTS: Sixty-eight participants completed the study. Significant results (P < 0.001) is found in wheezing, nausea, etc and in the cardinal symptoms such as breathlessness, cough, and expectoration. Statistically significant changes were found in LCQ, SGRQ, and PEFR parameters. No adverse events were reported during the study period. CONCLUSION: Talisadi Churna may be found effective in conditions such as Chronic Bronchitis. Based on the promising results of this study, randomized controlled trials with adequate sample size may be planned on Talisadi Churna in Chronic Bronchitis compared to standard care or as an add-on therapy with conventional medicine. Therefore TC can be further evaluated for incorporating it under the standard measure for management of CB.
Keywords: Chronic bronchitis, Kaphaja Kasa, Talisadi Churna
|How to cite this article:|
Tomar R, Yadav B, Singh H, Hetalben A, Khanduri S, Sharma BS, Rana R, Singhal R, Chandrasekhararao B, Srikanth N, Dhiman KS. A clinical study to evaluate the efficacy of Ayurvedic intervention in management of chronic bronchitis. J Res Ayurvedic Sci 2022;6:101-8
|How to cite this URL:|
Tomar R, Yadav B, Singh H, Hetalben A, Khanduri S, Sharma BS, Rana R, Singhal R, Chandrasekhararao B, Srikanth N, Dhiman KS. A clinical study to evaluate the efficacy of Ayurvedic intervention in management of chronic bronchitis. J Res Ayurvedic Sci [serial online] 2022 [cited 2023 Feb 2];6:101-8. Available from: http://www.jrasccras.com/text.asp?2022/6/3/101/360159
| Introduction|| |
India has 32% of the global disability-adjusted life years (DALYs) from chronic respiratory diseases due to decline in lung function, smoking, air pollutants from noxious environmental substances, and psychiatric co-morbidity.,,, Productive cough in the sputum and airflow obstruction for at least three months in 2 consecutive years are the major symptoms of chronic bronchitis (CB). Patients with CB symptoms have a higher mortality risk as it develops chronic obstructive pulmonary disease (COPD) related death. Global initiative for chronic obstructive lung disease suggests that COPD will rise from the sixth to the third most common cause of death worldwide by 2020. The classical sign and symptoms of Kaphaj Kasa are equatable to CB.Talisadi Churna (TC), a polyherbal Ayurveda, is widely used to treat ailments of the respiratory tract. Being a commonly prescribed Ayurveda medicine, the efficacy of TC needs to be studied among defined conditions such as CB. Thus, the present study was planned, to evaluate the effect of TC in managing CB.
| Materials and Methods|| |
The study was an open-label, single-arm, prospective study.
The study participants were enrolled from the outpatient department of Central Ayurveda Research Institute for Respiratory Disorders (CARIRD), Patiala, (Punjab, India), from June 2018 to June 2019.
Patients between 18 and 70 years who had CB for two years or more with stable symptoms for the past two weeks—i.e., unchanged amount and color of daily sputum, had FEV1 levels above 80%, and were willing to participate in the study were considered.
Patients with a history of pulmonary ailments such as emphysema, bronchial asthma, tuberculosis, chronic illnesses like diabetes mellitus, patients with poorly controlled hypertension (160/100 mm Hg), patients on prolonged (> 6 weeks) medication regimens (TC powder was administered orally in a dose of 3 gm thrice a day with honey (3 gm) till 12 weeks before food twice a day), and patients with severe systemic illnesses were excluded from this study.
TC powder was administered orally in a dose of 3 gm thrice a day with honey (3 gm) before food twice a day for 12 weeks. The visits were scheduled at interval of two weeks, i.e., on day 0, 14, 28, 42, 56, 70, and 84. During the first visit and at the end of the treatment period (day 84), laboratory tests, and subjective assessments like leicester (Leicester Cough Questionnaire (LCQ), St. George’s Respiratory Questionnaire (SGRQ), change in peak expiratory flow rate (PEFR) and FEV1% etc) were conducted. The participants’ post-treatment follow-up was conducted four weeks after the completion of the study.
Primary outcome measures were change in Leicester Cough Questionnaire (LCQ) Score and the number of patients who did not have an episode of acute exacerbation from baseline to day 98.
Secondary outcome measures were change in St. George’s Respiratory Questionnaire (SGRQ) Score for Quality-of-life, Functional/Exercise capacity [change in peak expiratory flow rate (PEFR) and FEV1%], and incidence of adverse events.
The sample size was calculated on the basis of assumption of detecting a change in subjective as well as objective Parameters of Chronic Bronchitis pre- and post-treatment based on the results of the previous studies and the standard deviation of 4.5 points with 95% confidence level (α =0.05) and 80% power. The obtained sample size was 39.73. Expecting a dropout rate of 25%, the final sample size for the study was taken as 50.
The continuous data were checked for normality using the Kolmogorov- Smirnov test. The parameters for which the data was normally distributed have been presented as Mean (SD) and compared using paired sample t–test for evaluating the change from baseline to the end of the treatment period. The parameters for which data does not meet the normality hypothesis have been presented as Median (Min–Max) and have been compared by the Wilcoxon sign rank test. The descriptive data has been presented as a number (%). A p-value of <0.05 has been considered significant. The analysis has been done using STATA version 16.1.
| Results|| |
A total of 97 patients with respiratory symptoms were screened within four months of the study as per the inclusion criteria (August 2018 to January 2019), and 75 patients were enrolled (as per inclusion criteria). A total of 68 participants completed the study, and 07 patients dropped out of the study (One participant participants were withdrawn away from the study site, and 04 participant due to poor drug compliance) Imputation was applied to data of 03 participants for statistical analysis [Figure 1]. Hence, the analysis includes data from 71 subjects. The flow of study participants is provided in [Figure 1].
Majority of the participants were female (66.2%). The details of baseline characteristics are depicted in [Table 1]. Significant improvement (P < 0.001) was found in all the three domains i.e. physical, psychological and social parameters of Leicester Cough Questionnaire Score on each of the scheduled follow-ups [Table 2]. Significant improvement (p value <0.001) was also found in St. George Respiratory Questionnaire Score on Symptoms, Activity and impact domain during all the follow-up vsits [Table 3]. Significant improvement (p value <0.001) of FEV1% and PEFR parameters are depicted in [Table 4]. Effect of TC on the laboratory investigations are in [Table 5]. No significant changes were observed in Hematological and Biochemical parameters. Improvement in disease-specific Ayurveda parameters at different time intervals are depicted in [Figure 2].
|Figure 2: Effect of Talisadi churna on the clinical features of Kaphaja Kasa (stable chronic bronchitis)|
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Improvement in Chief complaints of CB such as breathlessness, wheezing, cough and expectoration are demonstrated in [Figure 3]. Leicester Cough Questionnaire (LCQ) Score and St. George Respiratory Questionnaire Score is in [Figure 4] and [Figure 5] respectively.
|Figure 5: St. George Respiratory Questionnaire Score on symptoms, activity, and impact domain|
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| Discussion|| |
Out of 71 participants, 36 had history of allergy to some material and out of them, 18 participants were allergic to dust. Majority of participants 61 (85.9%) were having average emotional stress and 09 (12.7%) participants were having moderate emotional stress while only 01 (1.4%) was having too much emotional stress in his life. Statistical significant (P < 0.001) result were found in
Among all participants, 11 participants were on rescue medicine for cough, and for 09 participants, Ayurveda medicines were prescribed. 02 participants have taken conventional medicine and one patient had taken homeopathy medicines for cough.
CB is the independent risk factor for subjects younger than 50 years, but not among subjects above 50 years old. Most female homemakers had CB, which may have been caused by exposure to factors such as fumesand dust while performing home tasks. House and silica dust inhalation is also associated with CB manifestation.,,,,, The individuals with higher socio economic status may have less risk to occupational exposures. Disturbed sleep was observed in majority of patients of CB. It is also established that, obstructive sleep apnea is common in respiratory diseases. TC is widely used to treat ailments of respiratory tract. Piperine found in Piper longum Linn. is effective in reducing productive cough and it has anti-mycobacterial activity,Cinnamomum Zeylanicum Blume, Zingiber officinale Rosc and Piper longum Linn are usually indicated in cold and cough due to their anti-nociceptive and anti-inflammatory effects,,,,,Cinnamomum Zeylanicum Blume, Elettaria cardamomum Maton, Piper longum Linn, Bambusa bambos, cane sugar have an antihistaminic effect in bronchial conditions.Bambosa aruninaceae Wild is also having anti-inflammatory properties. The result of the present study also proves the safety of the TC as no ADR/AE was observed. Further, laboratory investigations such as LFT and KFT were found within normal limits after the study period.
| Conclusion|| |
Based on the promising results of this study, randomized controlled trials with adequate sample size may be planned on TC in CB compared to standard care or as an add-on therapy with conventional medicine.
The limitation to the present study is that it was a single arm open label study. Future study with radiological parameters should also be included. Cases of CB in children and geriatric population were not included in the study. Investigation parameters such as X-Ray chest, total lung capacity were not performed.
A single herbal formulation demonstrated that it can be used for management of CB in managing CB with no incidence of AE and disease progression during the study duration.
Trial registration number: CTRI/2018/01/011549 (Clinical Trial Registry of India)
Financial support and sponsorship
Central Council for Research in Ayurvedic Sciences, Ministry of Ayush, Govt. of India and Directorate of Ayush, Pharmacy of Central Ayurveda Research Institute for Drug Development, Kolkata.
Conflict of interest
| Summary of the “Take Home” Message|| |
The present study proves that, Talisadi Churna, a poly herbal powdered Ayurveda formulation is safe and effective to improve the clinical features to act against pathophysiology of chronic bronchitis without any adverse effect.
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[Figure 1], [Figure 2], [Figure 3], [Figure 4], [Figure 5]
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