| CTRI Number |
CTRI/2025/11/097374 [Registered on: 13/11/2025] Trial Registered Prospectively |
| Last Modified On: |
28/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda Preventive |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Management Of Tamaka Shwasa Through Tejovatyadi Ghrut |
|
Scientific Title of Study
|
A Clinical Study Of Charakokta Tejovatyadi Ghrut In The Management Of Tamaka Shwasa W.S.R. 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 |
Dr VARSHA TIWARI |
| Designation |
MD SCHOLAR |
| Affiliation |
Govt.Ayurveda College Nipaniya Rewa M.P |
| Address |
Dept.of Samhita Siddhant Govt.ayurveda college nipaniya
rewa m.p
Rewa
MADHYA PRADESH
486001
India
486001
India Rewa MADHYA PRADESH 486001 India |
| Phone |
9399898774 |
| Fax |
|
| Email |
varshatiwari997@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr VARSHA TIWARI |
| Designation |
MD SCHOLAR |
| Affiliation |
Govt.Ayurveda College Nipaniya Rewa M.P |
| Address |
Dept.of Samhita Siddhant Govt.ayurveda college nipaniya
rewa m.p
Rewa
MADHYA PRADESH
486001
India
486001
India Rewa MADHYA PRADESH 486001 India |
| Phone |
9399898774 |
| Fax |
|
| Email |
varshatiwari997@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr S N TIWARI |
| Designation |
PROFESSOR |
| Affiliation |
Govt.Ayurveda College Nipaniya Rewa M.P |
| Address |
Dept.of Samhita Siddhant Govt.ayurveda college nipaniya
rewa m.p
Rewa
MADHYA PRADESH
486001
India
Rewa MADHYA PRADESH 486001 India |
| Phone |
9827519119 |
| Fax |
|
| Email |
drsntiwari9@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Govt Ayurveda College Nipaniya Rewa MP |
| Address |
Govt Ayurveda
College Nipaniya
Rewa
Madhya Pradesh 486001 |
| 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 VARSHA TIWARI |
Govt.Ayurveda College Nipaniya Rewa M.P |
Dept.of Samhita Siddhant Govt.ayurveda college nipaniya
rewa m.p
Rewa
MADHYA PRADESH
486001
India Rewa MADHYA PRADESH |
09399898774
varshatiwari997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional Ethics Committee Govt.Ayurveda college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J459||Other and unspecified asthma. Ayurveda Condition: TAMAKASVASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Tejovatyadi Ghrut, Reference: Ch. Chi. 17 by 141 to 144, Route: Oral, Dosage Form: Ghrita, Dose: 12(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: Lukewarm Water), Additional Information: NIL |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients having age in between 16 to 70 years of any gender.
Chronicity less than 1 year
Patients having classical signs and symptoms of Tamaka Shwasa.
No recent respiratory infections or exacerbations.
Patients willing for the trial and ready to give informed consent.
|
|
| ExclusionCriteria |
| Details |
Patients of age less than 16 and greater than 70 years.
Patients not willing for the trial or not ready to give informed consent.
Patients who are using Bronchodilator Inhaler.
Uncontrolled hypertension & diabetes, cardiovascular disease, or renal/hepatic impairment, and history of active tuberculosis or pulmonary malignancy.
Diagnosis of COPD, Bronchiectasis, Interstitial Lung Disease, Vocal Cord Dysfunction, or Cystic Fibrosis.
Pregnant and lactating women.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
improvement in subjective parameters like Ativativraveg Shwasa Sannirudhyate Kasa Uddhavamsate kantha Ghurghurak Ucchritaksha Pratamyati Lalaten Svidyate Trut Visushkasyam
|
on 0 days to 21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
improvement in subjective parameters like Ativativraveg Shwasa Sannirudhyate Kasa Uddhavamsate kantha Ghurghurak Ucchritaksha Pratamyati Lalaten Svidyate Trut Visushkasyam
|
on 0 days to 21 days |
|
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
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 3 |
|
Date of First Enrollment (India)
|
30/04/2026 |
| 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="2" 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
|
TITLE A CLINICAL STUDY OF CHARAKOKTA TEJOVATYADI GHRUT IN THE MANAGEMENT OF TAMAKA SHWASA W.S.R. TO BRONCHIAL ASTHMA INTRODUCTION Shwasa word is used to denote respiration and exchange of air in the body The word Shwasa is used for both physiological and pathological conditions Tamaka Shwasa is a chronic respiratory disorder described in Ayurvedic classics closely correlated with Bronchial Asthma in modern medicine It is one of the five types of Shwasa Roga respiratory diseases Tamaka Shwasa is primarily caused by the vitiation of Vata and Kapha doshas leading to obstruction in the respiratory channels Pranavaha Srotas Resulting in difficulty in breathing wheezing and a sense of chest tightness It is typically characterised by recurrent attacks of breathlessness especially worsened at night and early morning NEED OF RESEARCH Indian study on epidemiology of asthma respiratory symptoms and chronic bronchitis in adults estimated that national burden of asthma at 17.23 million of population with an overall prevalence of 2.05 percent There are many drugs in modern medicine which do have potent bronchodilators and antispasmodic effect but none of them has got a curative potential and they are also required to be given for a very long duration of time On the other hand prolonged use of these drugs is not good for overall health as they have many adverse effects with systemic manifestations The need of some safe and potential ideal anti-asthmatic drug is always felt by medical fraternity. So the present study has been planned to assess the anti-asthmatic effect of Tejovatyadi Ghrut LAKSHANA 1 Ativativraveg Shwasa 2 Sannirudhyate 3 Kasa 4 Uddhavamsate kantha 5 Ghurghurak 6 Ucchritaksha 7 Pratamyati 8 Lalaten Svidyate 9 Trut 10 Visushkasyam MATERIAL AND METHOD STUDY DESIGN Type of study An Open Labelled Randomized Clinical Trial with Pre and Post Design No of groups Single group Sample size 30 pt Study duration 2yr Duration of trial 21 days Follow up period 3 months Patients fulfilling the criteria of diagnosis and criteria of inclusion for the present study shall be randomly selected from the OPD and IPD of Government Autonomous Ayurveda College Nipaniya Rewa M P PROBABLE MODE OF ACTION USHNA VIRYA KATU VIPAKA Helps liquefy and expel the obstructed Kapha Deepana pachana Enhance digestive fire reduce formation of Ama sssssssssswhich is a root cause of chronic inflammation regulate the Pranavayu USHNA TIKSHNA LAGHU Helps in clearing the blocked channels Srotoshodhana Kaphavata shamak Prevents recurrent Kapha accumulation PIPPALI HARITAKI JIVANTI Rasayana effect Improves lung tissue strength Improve oja Enhance immunity GOGHRUT Yogvahi Enhance digestion and absorption Balya strengthens lungs DRUG REVIEW TEJOVATYADI GHRITAM Tejovatyadi Ghrut Mode of administration Oral medication Form Ghrut Dose 12 gm Time of administration Twice a day (Morning & evening) Abhakt kala Duration 21 days |