| CTRI Number |
CTRI/2024/10/075066 [Registered on: 10/10/2024] Trial Registered Prospectively |
| Last Modified On: |
13/08/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Virechana and Kulattha Guda in Shwasa Rog (BRONCHIAL ASTHMA)
|
|
Scientific Title of Study
|
A CLINICAL STUDY ON THE EFFECT OF VIRECHANA KARMA AND KULATTHA GUDA IN THE MANAGEMENT OF TAMAK SHWASA (BRONCHIAL ASTHMA)
|
| Trial Acronym |
Tamak Shwasa |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ayushi Srivastava |
| Designation |
PG SCHOLAR |
| Affiliation |
GOVERNMENT AYURVEDA COLLEGE AND HOSPITAL VARANASI |
| Address |
Department of Panchakarma Room No 11
Government Ayurveda College and Hospital Varanasi
Department of Panchakarma Room No 11
Government Ayurveda College and Hospital Varanasi
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
08349161526 |
| Fax |
|
| Email |
ayushisrivastava7570@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manish Mishra |
| Designation |
Reader |
| Affiliation |
GOVERNMENT AYURVEDA COLLEGE AND HOSPITAL VARANASI |
| Address |
Department of Kayachikitsa and Panchakarma Room No 11
Government Ayurveda College and Hospital Varanasi
Department of Kayachikitsa and Panchakarma Room No 11
Government Ayurveda College and Hospital Varanasi
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
9415896482 |
| Fax |
|
| Email |
manish.arnav@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ayushi Srivastava |
| Designation |
PG SCHOLAR |
| Affiliation |
GOVERNMENT AYURVEDA COLLEGE AND HOSPITAL VARANASI |
| Address |
Department of Panchakarma Room No 11
Government Ayurveda College and Hospital Varanasi
Department of Panchakarma Room No 11
Government Ayurveda College and Hospital Varanasi
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
08349161526 |
| Fax |
|
| Email |
ayushisrivastava7570@gmail.com |
|
|
Source of Monetary or Material Support
|
| Goverment PG Ayureda College AND Hospital Varanasi 221002 UP India |
|
|
Primary Sponsor
|
| Name |
Goverment PG Ayureda College AND Hospital Varanasi 221002 UP India |
| Address |
Goverment PG Ayureda College AND Hospital Varanasi 221002 UP India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Ayushi Srivastava |
Government P.G. Ayurveda College and Hospital Varanasi |
Department of Panchakarma, Government P.G Ayurveda College and Hospital
221002
VARANASI
UTTAR PRADESH
Varanasi
UTTAR PRADESH |
8349161526
ayushisrivastava7570@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, Government Ayurveda College and Hospital Varanasi U.P., Mahayogi Guru Gorakhnath AYUSH University, Gorakhpur, U.P. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J452||Mild intermittent asthma. Ayurveda Condition: TAMAKASVASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | virecana-karma, विरेचन-करà¥à¤® | (Procedure Reference: CHARAK SAMHITA CHIKITSASTHANA 17/12, Procedure details: Patient will be administered snehpana for 5-7 days followed by swedana.Then virechana aushadh will be administered followed by samsarjana karma. )
(1) Medicine Name: Aragvadhaphala Majja, Reference: charak sutra 25/40, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 100(ml), Frequency: od, Duration: 1 Days | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: KULATTHA GUDA, Reference: CHAKRADATT CHIKITSA 12/31-34, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Antarabhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: -USHNA JALA), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
â–ª Patients with classical signs and symptoms of Tamak Shwasa will be taken
for the study.
â–ª Patients between age group 16-60yrs
â–ª Patients irrespective of sex, religion,socio economic status, occupation and
habitat.
â–ª Patients having chronicity less than one year.
â–ª Patients who are Yogya of Virechana Karma. |
|
| ExclusionCriteria |
| Details |
Patients suffering from major systemic disorders, cardiac asthma, chronic
renal failure, topical pulmonary eosinophilia, tuberculosis, emphysema,
COPD, spontaneous pneumothorax, complicated bronchial asthma, lower
respiratory tract infections e.g ARDS, pneumonitis, hypertension, diabetes
mellitus, thyroid, pregnant women and lactating mothers.
â–ª Age less than 16 and more than 60 yrs.
â–ª Patients on drug dependence.
â–ª Patients having chronicity more than one year.
â–ª Patients Ayogya of Virechana.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mild relief in swasakashtata, kasa, ghurghurkam, urah parshwa peedyena |
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Complete relief in the Chief complaints of Tamak Shwasa & also Effective in Jwara Kasa & Hikka |
35 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
20/10/2024 |
| Date of Study Completion (India) |
14/05/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
Modification(s)
|
This study is an Open Randomized Comparative and Interventional Group Study trial on topic of A CLINICAL STUDY OF EFFECT OF VIRECHANA KARMA AND KULATTHA GUDA IN THE MANAGEMENT OF TAMAK SHWASA (BRONCHIAL ASTHAMA). This study includes 60 no. of patients,divided into two groups. GROUP A 30 Patients treated with Virechana Karma with the help of Aragvadha Phala Majja, in duration of 21 days. GROUP B 30 Patients treated with Kulattha Guda, in duration of 21 days. After completion of treatment course, there were two follow up with the interval of 7 days. First Follow Up at 7th day Second Follow Up at 14th day. Result obtained after statistical analysis: Group A: In this group, out of 30, maximum 14 patients (46.67%) got good improvement, while 15 patients (50%) got moderate improvement and 01 patient (03.33%) got mild improvement in overall subjective and objective parameters.
Group B: In this group, out of 30, maximum 19 patient (16.67%) got good improvement while 19 patients (63.33%) got moderate improvement and 06 patients (20%) got mild improvement in overall subjective and objective parameters.
Conclusion: Statistically significant difference was observed in trial group (Group-A) as compared to control group (Group-B) in terms of Shwasakastata, kasa, Ghurghurkam, Urah Parshwa Cha Peedyena, Lalate Swedana, Aseeno Labahte Saukhyam, TLC, ESR, AEC, S.IgE, FEV1, FVC, FEV1/EVC |