Protocol for an Open Labelled Randomised Comparative Clinical Study to Evaluate the Efficacy of Bharangyadi Madhuka versus Talishadi Churna in the Management of Tamaka Shwasa (Bronchial Asthma)

Abstract

Shwasa roga is a term used in classical texts to describe respiratory disorders. Acharyas have classified all respiratory diseases into five types of Shwasa rogas. Tamak Shwasa is one among them. [1]Tamaka Shwasa is usually correlated with bronchial asthma for having a resemblance in clinical signs and symptoms. Among five shwasa rogasTamak Shwasa represents a significant burden due to its chronicity, recurrent exacerbations, and the adverse effects of conventional bronchodilator and corticosteroid therapies. While various Ayurvedic interventions have been used to manage this condition, there exists a research gap regarding the comparative evaluation of Bharangyadi Madhuka and Talishadi Churna. Objective:This study aims to evaluate and compare the clinical efficacy and safety of Bharangyadi Madhuka versus Talishadi Churna in the management of Tamaka Shwasa (Bronchial Asthma). Methods:This open-labelled, parallel comparative clinical trial will be conducted at a single center. A total of 60 patients, aged 25–60 years and diagnosed with Tamaka Shwasa (corresponding to mild intermittent or mild persistent asthma per NAEPP criteria), will be enrolled. Subjects will be randomly allocated into two equal groups: • Group A (Intervention):[2] Patients will receive Bharangyadi Madhuka at a dose of 6?gm twice daily (BD) after meals, administered with a vishammatra of madhusarpi (in a 2:1 ratio). • Group B (Comparator): [3] Patients will receive Talishadi Churna at a dose of 6?gm BD after meals with honey. The treatment period is 21 days, with follow-up assessments on days 7, 14, and 21 during treatment and further follow-up on days 28, 35, and 42. Outcome assessments include detailed subjective symptom scoring (e.g., frequency, duration, and intensity of dyspnea, cough, and other related symptoms) and objective clinical criteria (such as the presence of wheezing, rhonchi, and accessory muscle use). Laboratory investigations (e.g., Hb, ESR, CRP, AEC, and pulmonary function tests) will be performed at the specified intervals to monitor safety and therapeutic effects. Data analysis will involve computing means, standard deviations, and appropriate statistical tests, with significance set at p < 0.05. Ethical Consideration: All patients will provide written informed consent prior to participation. The protocol has been approved by the Institutional Ethics Committee and will be registered with the Central Trials Registry-India (CTRI). Confidentiality, adherence to ethical guidelines, and appropriate reporting of adverse events will be ensured throughout the study. Expected Outcome:We hypothesize that Bharangyadi Madhuka will demonstrate a significant clinical benefit over Talishadi Churna in alleviating the symptoms of Tamaka Shwasa, thereby providing a potentially safer and cost-effective alternative in the management of bronchial asthma.

Introduction

Bronchial asthma, known as Tamaka Shwasa in Ayurveda, is a chronic respiratory condition marked by episodic breathlessness, wheezing, cough, and chest tightness. While modern treatments exist, they often have side effects. Ayurveda offers a holistic, natural approach with fewer adverse reactions, focusing on doshic balance. Despite various herbal formulations studied, limited comparative research exists between Bharangyadi Madhuka and the classical Talishadi Churna.

Study Objective:

The study aims to compare the clinical efficacy and safety of Bharangyadi Madhuka and Talishadi Churna in managing Tamaka Shwasa and to evaluate their impact on clinical and biochemical markers.

Methodology:

• Design: Open-label, parallel-group, comparative clinical trial.

• Location: Shri Krishna Ayush University, Kurukshetra.

• Participants: 60 patients (aged 25–60) with mild asthma (as per both Ayurvedic and modern criteria).

• Groups:

  • Group A: Bharangyadi Madhuka (Bharangi, Madhuka, Haritaki).

  • Group B: Talishadi Churna (8-herb blend + sugar).

• Duration: 21-day treatment with follow-ups until day 42.

Assessment Criteria:

• Subjective: Symptom frequency, duration, intensity, cough, wheezing, throat irritation, and quality of life using Ayurvedic scales.

• Objective: Blood tests (Hb, ESR, CRP, AEC), pulmonary function tests (PFT), and clinical signs (rhonchi, wheezing).

• Safety: Adverse events will be monitored and documented.

• Efficacy Grading: Based on percentage of clinical improvement (<25% to >75%).

Statistical Analysis:

Data will be analyzed using t-tests (or non-parametric equivalents) with significance at p < 0.05.

Ethical Compliance:

• Approved by the Institutional Ethics Committee.

• Registered with the Clinical Trials Registry of India (CTRI).

• Informed consent obtained and confidentiality maintained.

Conclusion

This protocol outlines an open labeled, parallel comparative clinical trial to assess the efficacy of Bharangyadi Madhuka versus Talishadi Churna in the management of TamakaShwasa (Bronchial Asthma). Through meticulous documentation of clinical and laboratory parameters over a defined follow up period, this study intends to fill a crucial research gap and potentially validate a novel Ayurvedic treatment strategy that may benefit patients suffering from asthma. Future large scale studies could further consolidate these findings and support the integration of effective Ayurvedic treatments into modern clinical practice.

References

[1] Shukla V, Tripathi B. Charaka Samhita of Agnivesha (Hindi).Varanasi: Krishnadas Academy; reprint ed. 2000, Chikitsa sathan, Chapter 17, Verse 56. [2] Shri Bhrma Shankar Shastri, Yogaratnakara, Shwasa Rogadhikara Chikitsa, verse24 12/14. Varanasi: Chaukhamba Sanskrit Sansthan; 2003 P. no. 435. [3] Tripathi B. Sharangadhara Samhita. Varanasi: Chaukhambha Surbharti Prakashan; 2017. Madhyamakhanda. Chapter 6, verse 34-35. [4] Golwalla Aspi F, Golwalla Sharukh A. Golwalla”s Medicine for students 25th ed. New Delhi (India) Jaypee Brothers Medical Publishers (P) Ltd. 2017 p. 118. [5] Singh V, Sinha HV, Gupta R. Barriers in the management of asthma and attitudes towards complementary medicine. Respiratory Medicine 2002; 96:835-840. [6] Ellwood P, Asher I, Billo N, et al. The Global Asthma Network rationale and methods for Phase I global surveillance: prevalence, severity, management and risk factors. Eur Resp J 2017;49:1601605. [7] Shukla V, Tripathi B. Charaka Samhita of Agnivesha (Hindi).Varanasi: Krishnadas Academy; reprint ed. 2000, Chikitsa sathan, Chapter 17, Verse 56.

Copyright

Copyright © 2025 Dr. Adbhut Kumar Mundhara, Dr. Neelam Kumari, Dr. Neha Lamba. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.