| CTRI Number |
CTRI/2025/02/080600 [Registered on: 14/02/2025] Trial Registered Prospectively |
| Last Modified On: |
06/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Ayurveda in Tamaka Shwasa |
|
Scientific Title of Study
|
Efficacy of Vasadi Kwath versus Ashwagandhadi Churna in the management of
Tamaka Shwasa w.s.r. Bronchial Asthma: An open label randomised comparative
study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Dharnendra Jain |
| Designation |
PG SCHOLAR |
| Affiliation |
Ayurvedic And Unani Tibbia College And Hospital |
| Address |
Seminar room, PG Dept of Kayachikitsa, Ayurvedic and Unani Tibbia College and Hospital, Karol Bagh, New Delhi
Central
DELHI
110005
India |
| Phone |
9167605897 |
| Fax |
|
| Email |
djain7547@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sujata Yadav |
| Designation |
Associate Professor and Head of Department |
| Affiliation |
Ayurvedic and Unani Tibbia College and Hospital |
| Address |
Room No. 6, PG Dept of Kayachikitsa, Ayurvedic and Unani Tibbia College and Hospital, Karol Bagh, New Delhi
Central
DELHI
110005
India |
| Phone |
9810571653 |
| Fax |
|
| Email |
sujatakcdelhi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sujata Yadav |
| Designation |
Associate Professor and Head of Department |
| Affiliation |
Ayurvedic and Unani Tibbia College and Hospital |
| Address |
Room No. 6, PG Dept of Kayachikitsa, Ayurvedic and Unani Tibbia College and Hospital, Karol Bagh, New Delhi
Central
DELHI
110005
India |
| Phone |
9810571653 |
| Fax |
|
| Email |
sujatakcdelhi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ayurvedic and Unani Tibbia College and Hospital, Karol Bagh, New Delhi - 110005 |
|
|
Primary Sponsor
|
| Name |
Ayurvedic and Unani Tibbia College and Hospital |
| Address |
Ayurvedic and Unani Tibbia College and Hospital, Karol bagh, New Delhi -110005 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sujata Yadav |
Ayurvedic and Unani Tibbia College and Hospital |
Seminar Room, PG
Department of
Kayachikitsa
Central
DELHI
Central
DELHI |
9810571653
sujatakcdelhi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Ayurvedic and Unani Tibbia college and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J454||Moderate persistent asthma. Ayurveda Condition: TAMAKASVASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Vasadi Kwath, Reference: Bhaisajya Ratnavali, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: Maricha Churna), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Ashwagandhadi Churna, Reference: Sahasrayoga, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: Lukewarm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient has asthma with severity ranging from Intermittent asthma to Moderate Persistent
asthma, according to the NAEPP 2020 Guidelines.
2. FEV1 more than 60%.
3. Chronicity less than 10 years
4. Patient presenting with features of Tamaka shwasa as in ayurvedic classical textbooks |
|
| ExclusionCriteria |
| Details |
1.Patients on prolonged (more than 6 weeks) medication with corticosteroids, bronchodilators, mast cells stabilizers, antidepressants, anticholinergics, or any other drugs that may have an influence on the outcome of the study.
2.Patients who have a past history of Atrial fibrillation, Acute Coronary Syndrome, Myocardial Infraction, stroke or severe Arrhythmia in last 6 months
3.Patient having systemic illness necessitating long term drug treatment like TB, carcinoma, endocrine disorders, concurrent major liver or renal disorders, psychological disorders, neurological disorders like epilepsy, meningitis, stroke etc.
4.Patients who have completed participation in any other clinical trial during the past 6 months
5.Patient having pulmonary diseases other than asthma
6.Patient with Diabetes mellitus (FBS more than 126 mg/dl)
7.Patient with poorly controlled Hypertension (Systolic more than 140mm Hg and Diastolic more than 90 mm of Hg)
8.Patient having SPO2 less than 90%
9.Emergency patients requiring O2 inhalation
10.Hypersensitivity to any of the content of the trial drug
11.Pregnant and lactating women
12.Smoker or alcoholic or drug abusers |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Evaluate the changes in frequency and severity of asthma symptoms as assessed by grading
of clinical symptoms, Asthma control questionnaire.
Proportion of participants having 50% relief in the grading of clinical symptoms will be considered as improvement |
Day 1, 91 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Measure changes in pulmonary function parameters such as FEV1, FVC, PEFR, before and
after treatment.
Evaluate improvement in quality of life using Asthma quality of life questionnaire
Evaluate the reduction in serum IgE level and Absolute eosinophil count. |
Day 1, 91 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/03/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The text discusses Tamaka Shwasa, an Ayurvedic disorder akin to Bronchial Asthma, which affects the respiratory system by vitiating the Prana Vayu (life force responsible for respiration). This condition is caused by an imbalance of Kapha and Vata doshas, influenced by factors like environmental pollution, dietary habits, and psychological stress. It is characterized by obstruction in the airways, leading to symptoms such as wheezing and difficulty breathing. Tamaka Shwasa is considered a chronic, recurrent disorder, with environmental and lifestyle factors increasing its prevalence globally. Ayurveda suggests treatments that focus on clearing the Kapha obstruction in the respiratory system, restoring normal Vayu function, and using herbs with anti-allergic properties. Although there are indigenous Ayurvedic treatments, the need for further clinical studies is emphasized to support their efficacy. The goal is to manage asthma with minimal symptoms, prevent exacerbations, and reduce healthcare costs. |