| CTRI Number |
CTRI/2025/09/094171 [Registered on: 03/09/2025] Trial Registered Prospectively |
| Last Modified On: |
01/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Pharmaceutico-Analytical and Exploratory Study of Shila Sindoor in the Treatment of Bronchial Asthma (Tamaka Swasa)
|
|
Scientific Title of Study
|
A Pharmaceutico Analytical And Exploratory Trial Of Shila Sindoor In The Management Of Tamak Swasa (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 Manoj Barupal |
| Designation |
MD scholar |
| Affiliation |
PGIA JODHPUR |
| Address |
Dept of Rasa Shastra Post Graduate Institute of Ayurved DSRRAU
Jodhpur
Rajasthan India
324307
Dept of Rasa Shastra Post Graduate Institute of Ayurved DSRRAU
Jodhpur
Rajasthan India
324307
Jodhpur
RAJASTHAN
342307
India |
| Phone |
9358584716 |
| Fax |
|
| Email |
manojbarupal1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manisha Goyal |
| Designation |
Associate Professor |
| Affiliation |
PGIA JODHPUR |
| Address |
Dept of Rasa Shastra Post Graduate Institute of ayurved DSRRAU Jodhpur India
Dept of Rasa Shastra Post Graduate Institute of ayurved DSRRAU Jodhpur India
Jodhpur
RAJASTHAN
342037
India |
| Phone |
8890242078 |
| Fax |
|
| Email |
manishagoyal29@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manoj Barupal |
| Designation |
MD scholar |
| Affiliation |
PGIA JODHPUR |
| Address |
Dept of Rasa Shastra Post Graduate Institute of ayurved DSRRAU Jodhpur India
Dept of Rasa Shastra Post Graduate Institute of ayurved DSRRAU Jodhpur India
Jodhpur
RAJASTHAN
342307
India |
| Phone |
09358584716 |
| Fax |
|
| Email |
manojbarupal1997@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr S R Rajasthan Ayurved University Jodhpur Rajasthan
342037 |
|
|
Primary Sponsor
|
| Name |
Post Graduate institute of Ayurved, Jodhpur,Rajasthan |
| Address |
PGIA Dr S R Rajasthan Ayurved University Jodhpur Rajasthan
342037 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Manoj Barupal |
barupallo ka mohalla didwana kuchaman 341533 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Manoj Barupal |
Sanjeevani hospital |
Room NO. 10 PGIA Dr S R RAJASTHAN Ayurved University Jodhpur 342307 Rajasthan
Jodhpur
RAJASTHAN |
9358584716
manojbarupal1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
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: shila sindoor , Reference: rasamrutam by acharya yadavji trikamji , Route: Oral, Dosage Form: Churna/ Powder, Dose: 125(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Age between 18-60 years irrespective of sex.
2. Patients having cardinal sign and symptoms as in Ayurvedic classics and contemporary medicine.
3. Night symptoms more than twice per month but less than once a week.
4. Patients who meet reversibility criteria.
5. FEV1 is grater then 80 pracent of the predicted value.
6. Diagnosed mild and moderate cases of asthma (GINA) without any co morbidity. |
|
| ExclusionCriteria |
| Details |
1. Patients having other associated diseases like LVFURTI, Bronchiectasiscases of tuberculosis, IL.D
2. Patients having major systemic illness.
3. Patients having Renal and Hepatic disease.
4. Patients with HIV Positive.
5. Pregnant and lactating mothers should be excluded.
6. Patients without written consent form. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| change in subjective parameters |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvememt in quality of life of patient |
30 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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
02/02/2026 |
| 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="0"
Months="0"
Days="30" |
|
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
|
Summary:
Tamaka Swasa, which closely resembles bronchial asthma, is a leading cause of dyspnea (shortness of breath). Asthma is a major noncommunicable disease, affecting approximately 1.2-6.3% of adults globally, with around 300 million people suffering worldwide. This number has increased by 50% over the past decade. Conventional treatments, such as bronchodilators and corticosteroids, are effective but have long-term adverse effects, necessitating the need for alternative therapies.
This case study aims to explore the role of Shila Sindoor and Trikatu Churna in the management of Tamaka Swasa (Bronchial Asthma). The study seeks to validate their effectiveness as an Ayurvedic alternative for asthma treatment.
In both Ayurveda and Modern Medicine, Swasa refers to difficulty in breathing or asthma, caused by both host factors (Nija Hetu—Dosha Dushti and Aam) and environmental factors (Aagantuja Hetus—dust, smoke, wind, etc.). According to Sushruta, Swasa occurs when Vata (the vital force) becomes vitiated, obstructing the respiratory passage due to Kapha, leading to difficulty in breathing. Tamaka Swasa is classified as a Vata-Kapha type of Swasa and corresponds closely to bronchial asthma in modern medicine. Asthma is a chronic inflammatory disease of the airways, characterized by episodic dyspnea, chest tightness, wheezing, and coughing, especially at night or early morning.
Need for the Study:
To reduce reliance on steroids for asthma control by exploring Ayurvedic formulations as alternative treatments.
To evaluate the potential of Shila Sindoor and Trikatu Churna in managing Tamaka Swasa, as clinical research on this combination is currently lacking.
This study aims to provide a safer, alternative approach to asthma management, addressing the growing need for more sustainable treatments. |