| CTRI Number |
CTRI/2025/03/083297 [Registered on: 25/03/2025] Trial Registered Prospectively |
| Last Modified On: |
05/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare efficacy of Dashmulyadi Kwatha and Shringyadi churna in the management of Tamaka Shwasa with special reference to Bronchial Asthma |
|
Scientific Title of Study
|
A comparative study to evaluate the efficacy of Dashmulyadi Kwatha and Shringyadi Churna in the management of Tamaka Shwasa with special reference to Bronchial Asthma |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kimmi Seth |
| Designation |
Phd Research Scholar |
| Affiliation |
Motherhood Ayurveda Medical College |
| Address |
Kayachakista department
OPD Number 1
Motherhood Ayurveda Medical College Roorkee
District Haridwar
Hardwar
UTTARANCHAL
247661
India |
| Phone |
8449609809 |
| Fax |
|
| Email |
luckykimtim@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Amitabh Singh |
| Designation |
Professor Kayachikitsa |
| Affiliation |
Desh Bhagat University |
| Address |
Department of Kayachikitsa
OPD Number 24
Desh Bhagat Ayurvedic Medical college
Mandigobindgarh
Punjab
Fatehgarh Sahib
PUNJAB
147301
India |
| Phone |
9815526868 |
| Fax |
|
| Email |
asinghay@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Amitabh Singh |
| Designation |
Professor Kayachikitsa |
| Affiliation |
Desh Bhagat University |
| Address |
Department of Kayachikitsa
OPD Number 24
Desh Bhagat Ayurvedic Medical college
Mandigobindgarh
Punjab
Fatehgarh Sahib
PUNJAB
147301
India |
| Phone |
9815526868 |
| Fax |
|
| Email |
asinghay@gmail.com |
|
|
Source of Monetary or Material Support
|
| Motherhood Ayurved Medical College Roorkee
Post Bhagwanpur Tehsil Roorkee District Haridwar India Pin 247661 |
|
|
Primary Sponsor
|
| Name |
Dr.Kimmi Seth |
| Address |
Kharkhari near railway crossing Haridwar, Uttarakhand-249401 |
| Type of Sponsor |
Other [Self] |
|
|
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 Kimmi Seth |
Motherhood Ayurveda Medical College Roorkee |
Department of Kayachikitsa
OPD Number 1
Hardwar
UTTARANCHAL |
8449609809
luckykimtim@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee |
Approved |
| University Ethics Committee |
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 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Dashmulyadi Kwatha, Reference: Bhaishajya Ratnawali16/25-26, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 2 Months, anupAna/sahapAna: No, Additional Information: Patient will be given 300 gm of Dashmulyadi Kwatha at 15-15 days interval for total duration of 2 months. Fresh kwatha has to be prepared before consumption by adding 16 times of water into the 10 gms of raw Kwatha and boiling it on low flame till it reduces to one fourth times. | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shringyadi Churna, Reference: Chakradatta 12/9 Bhaishajya Ratnawali 16/29, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: Koshna jala), Additional Information: Patient will be given 150 gm of Shringyadi Churna at 15-15 days interval for total duration of 2 months. Patient has to consume 5 gm of Shringyadi Churna with koshna jala as anupana dravya. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient having classical features of Tamaka Shwasa.
Presence of symptoms of airflow obstruction 2 or more of cough, wheezing, dyspnoea.
Airflow obstruction is atleast partially reversible.
Oxygen saturation greater than 90 percent
Cases included from intermittent mildly persistent to moderate persistent asthma.
PEFR more than 60 percent of the predicted value.
|
|
| ExclusionCriteria |
| Details |
PEFR less than equals to 60 percent of the predicted value orless than 100 litre per min equals to Severe Exacerbation(Status Asthmaticus).
Blood Oxygen saturation less than 90 percent
Asadhya Lakshanas of Tamaka Shwasa.
The patient with history of Tuberculosis, COPD, Emphysema, Chronic airway obstruction, Status Asthmaticus, Cardiac asthma, CAD.
History of Endocrine disorders like diabetes mellitus, thyroidism.
known case of Hypertension
Other complicated respiratory diseases having any organic lesion such as tumor or any anatomical defect in airway.
If the patient exhibits short seasonal changes of less than 4 weeks duration.
Any other physical and surgically ill patient will be excluded.
Severe exacerbation inspite of medication.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Complete Remission
Markedly Improved
Moderately Improved
Mildly Improved
Unchanged |
15th day, 30th day, 45th day, 60th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Exacerbations in signs and symptoms |
30th day, 60 th day after the completion of trial. |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "120"
Final Enrollment numbers achieved (India)="120" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
04/04/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
A comparative clinical study will be undertaken to evaluate the efficacy of Dashmulyadi Kwatha and Shringyadi Churna in the management of Tamaka Shwasa w.s.r. Bronchial Asthma. In Group I Dashmulyadi kwatha will be given for total duration of 60 days and in Group II Shringyadi Churna will be given for total duration of 60 days. Clinical Assessment of the patients will be done on the basis of subjective and objective parameters at .15th, 30th , 45th and 60th day of the trial and Follow up will be done at 30 th day and 60th day after the completion of the trial. Inference will be made after application of the suitable statistical tests. |