| CTRI Number |
CTRI/2025/08/093746 [Registered on: 27/08/2025] Trial Registered Prospectively |
| Last Modified On: |
26/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To assess the role of Virechana Karma in Tamaka Shwasa (Bronchial Asthma) |
|
Scientific Title of Study
|
Randomized clinical study of Virechana Karma with Trivrit Modaka and Vyoshadi Gutika in Tamaka Shwasa (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 |
Nidhi Goswami |
| Designation |
Pg Scholar |
| Affiliation |
Himalayiya Ayurvedic PG Medical College and Hospital |
| Address |
Opd No 11 Department of Panchakarma Himalayiya Ayurvedic PG Medical College and Hospital Fathehpur Tanda Majri Grant Via Doiwala Dehradun 248140
Dehradun
UTTARANCHAL
248140
India |
| Phone |
8766382971 |
| Fax |
|
| Email |
nidhigoswami.dr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shrimant Gangaram Chavan |
| Designation |
Professor |
| Affiliation |
Himalayiya Ayurvedic Pg Medical College and Hospital |
| Address |
Opd No 11 Department of Panchakarma Himalayiya Ayurvedic Pg Medical College and Hospital Fathehpur Tanda Majri Grant Via Doiwala Dehradun 248140
Dehradun
UTTARANCHAL
248140
India |
| Phone |
7204863633 |
| Fax |
|
| Email |
drshrimantgc.bc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shrimant Gangaram Chavan |
| Designation |
Professor |
| Affiliation |
Himalayiya Ayurvedic Pg Medical College and Hospital |
| Address |
Opd No 11 Department of Panchakarma Himalayiya Ayurvedic Pg Medical College and Hospital Fathehpur Tanda Majri Grant Via Doiwala Dehradun 248140
Dehradun
UTTARANCHAL
248140
India |
| Phone |
7204863633 |
| Fax |
|
| Email |
drshrimantgc.bc@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Panchakarma Himalayiya Ayurvedic Pg Medical College and Hospital Fathehpur Tanda Majri Grant Via Doiwala Dehradun 248140 |
|
|
Primary Sponsor
|
| Name |
Nidhi Goswami |
| Address |
Opd No 11 Department of Panchakarma Himalayiya Ayurvedic Pg Medical College and Hospital Fathehpur Tanda Majri Grant Via Doiwala Dehradun 248140 |
| 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 |
| Nidhi Goswami |
Himalayiya Ayurvedic Pg Medical College and Hospital |
Opd No 11 Department of Panchakarma Himalayiya Ayurvedic Pg Medical College and Hospital Fathehpur Tanda Majri Grant Via Doiwala Dehradun 248140
Dehradun
UTTARANCHAL |
08766382971
nidhigoswami.dr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Minutes of Institutional Ethical 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 | Procedure | - | Deepana, Pachana, Abyantarasnehah, Sarvang Abyanggah-Nadiswedan, Virechana Karma, Sansarajan Krama | (Procedure Reference: C.Ci. 7/121, Procedure details: In two groups initially, for 5 days, Shunthi churna with lukewarm water will be given to
the registered patients for Deepana (enhancing appetite) and Pachana (enhancing
digestion). After assessing the patients Agni (digestive fire), Snehpana (oral
administration of unctuous substances) with Go ghrit will be started until attainment of
Samyak Snigdha Lakshana (optimal therapeutic internal oleation) for 3-7 days. This will
be followed by 3 days of external oleation with Til Tail and sudation with Dashmoola
decoction. The next morning, a suitable dose of Trivrit Modaka (group A) & vyoshadi
gutika (group B) with Anupana (vehicle) of luke warm water will be given on empty stomach for Virechana (purgation).)
(1) Medicine Name: Trivrit Modaka, Reference: C.K. 7/ 37-39, Route: Oral, Dosage Form: Modaka, Dose: 50(g), Frequency: od, Duration: 23 Days(2) Medicine Name: Vyoshādi Gutikā, Reference: C.K. 7/ 46-49, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 50(g), Frequency: od, Duration: 23 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Patients having classical signs and symptoms of Tamaka Shwasa( Bronchial Asthma)
PEFR 60-90 percent
Subjects willing to participate in the study
Previously treated cases of Bronchial Asthma with no active medication.
Patient fit for Virechana
|
|
| ExclusionCriteria |
| Details |
1.The patient with chronic respiratory disease like history of pulmonary tuberculosis,
emphysema, pulmonary effusion, COPD other complicated respiratory disease such
as tumor or any anatomical defect in airways.
2.Pregnant and lactating women.
3.Severe and systemic diseases like uncontrolled hypertension, uncontrolled Diabetes,
CKD (chronic kidney disease), severe chronic metabolic disorders.
4.Bronchial asthma having a severe attack who requires oxygen and nebulization
support.
5.Subjects with other systemic disorders which may interfere with the course of the
study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
REDUCTION IN SYMPTOMS LIKE Swasakrichrata, Peenasa,Kasa,Ghurghurkam, Uraha Pida, Kasatah
Sannirudhyate, Asino Labhate
Saukhyam |
3 WEEKS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| TO NORMNALIZE PEAK FLOW METER READING AND ABSOLUTE EOSINOPHIL COUNT |
4 WEEKS |
|
|
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)
|
08/09/2025 |
| 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="6"
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
|
Tamaka Shwasa is a disease of respiratory system in Ayurveda. It originates from Pittasthana and it is caused due to the vitiation of Kapha and Vata and manifested through Pranavaha Strotas. When Vata allied with Kapha obstructed in the Pranavaha Strotas gets more aggravated and in turn causes Shwasa. I will do the study regarding the efficacy of Trivrit Modaka and Vyoshadi Gutika for the management of Tamaka Shwasa under the topic: Randomized Comparative Study of Virechana Karma with Trivrit Modaka and Vyoshadi Gutika in Tamaka Shwasa (Bronchial Asthma). My study is not biased. It is anticipated that the results will contribute to evidence based practice. |