| CTRI Number |
CTRI/2025/04/084455 [Registered on: 09/04/2025] Trial Registered Prospectively |
| Last Modified On: |
01/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Screening |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the efficacy of Vaman Karma and Shirishadi Avaleha in the management of Tamakshwas |
|
Scientific Title of Study
|
Randomized controlled clinical study of add on effect of Vaman Karma & Shirishadi Avaleha in the management of Tamakshwas with special reference to Bronchial Asthama |
| Trial Acronym |
Interventional |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gauri Sadashiv Belpatre |
| Designation |
MD Scholar Panchakarma (Ayurveda) |
| Affiliation |
LRP Ayurvedic Medical College and Hospital Islampur |
| Address |
Department of Panchkarma Unit 1 LRP Medical college and Hospital
Post Graduate Institute and Research Centre Islampur
Sangli,Maharashtra
Sangli
Sangli
MAHARASHTRA
415409
India |
| Phone |
7083105089 |
| Fax |
|
| Email |
belpatregauri@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepak Kumar Parida |
| Designation |
HOD |
| Affiliation |
LRP Ayurvedic Medical College And Hospital Islampur |
| Address |
Department of Panchkarma Unit 1 LRP Medical college and Hospital
Post Graduate Institute and Research Centre Islampur
Sangli,Maharashtra
Sangli
MAHARASHTRA
415409
India |
| Phone |
8830333050 |
| Fax |
|
| Email |
dpkparida@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepak Kumar Parida |
| Designation |
HOD |
| Affiliation |
LRP Ayurvedic Medical College And Hospital Islampur |
| Address |
Department of Panchkarma Unit 1 LRP Medical college and Hospital
Post Graduate Institute and Research Centre Islampur
Sangli,Maharashtra
Sangli
MAHARASHTRA
415409
India |
| Phone |
8830333050 |
| Fax |
|
| Email |
dpkparida@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| LRP Ayurvedic Medical College and Hospital Post Graduate Institute
and Research Centre Islampur Sangli-415409,Maharashtra,India |
|
|
Primary Sponsor
|
| Name |
LRP Ayurvedic Hospital and Research Centre |
| Address |
LRP Ayurvedic Medical College and Hospital Post Graduate Institute
and Research Centre Islampur Sangli-415409,Maharashtra,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 Gauri Sadashiv Belpatre |
LRP Ayurvedic Medical College and Hospital |
Department of
Panchkarma Unit 1
LRP Medical college
and Hospital Post
Graduate Institute and
Research Centre
Islampur Sangli-415409
Maharashtra
Sangli
MAHARASHTRA |
7083105089
belpatregauri@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee 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 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Shirishadi Avaleha, Reference: Sharangdhar samhita, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 12(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Koushna jalpan), Additional Information: - | | 2 | Intervention Arm | Procedure | - | vamana-karma/ pracCardanam, वमन-कर्म/ प्रच्छर्दनम् | (Procedure Reference: Charak samhita chikitsa sthan chapter 17, Procedure details: Purvakarma:- 1.Deepan,Pachan - 2to3 days -Shunthi siddha jal 2. Abhyantar snehapan - 3 to 7 days, till samyak snigdha lakshan seen- Shudha go ghrit Vishrantikal- 1 day- Sarvang abhyanga & swedan. Pradhan karma - Sarvang abhyanga & swedan,Vaman karma with Madanphal yog. Paschat karma- 3 to 7 days - Sansarjan kram- peya,vilepi,yush,etc.)
(1) Medicine Name: Shirishadi Avaleha, Reference: Sharangdhar samhita, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 12(g), Frequency: bd, Duration: 30 Days |
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1.patient fulfilling classical lakshanas according to tamakshwas.
2.Irrespective of religion economical status occupation etc.
3.Vaman yogya patient
|
|
| ExclusionCriteria |
| Details |
1.uncontrolled DM and HTN
2.pregnant or lactating mother
3.HIV positive cases
4.patient suffering from any systemic disease. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the efficacy of vaman karma and shirishadi avaleha in the management of tamakshwas with special reference to Bronchial Ashtama. |
48 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To reduce the lakshanas of tamakshwas in 48 days.
To study the literature related concept of tamakshwas.
To study the concept of vaman karma.
To study the efficacy of shirishadi avaleha.
|
48 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
23/05/2025 |
| 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="2" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Now a day’s most of the people facing of the Tamakshwas. It is well known for its recurrence & chronicity.Bronchial Asthma mentioned in modern medicine closely resembles with Tamakshwas. Charak described lakshanas of Tamakshwas like Shwaskeichata, kaas, kanthodhvamsanam,asinolabhatesaukhyam, ghurghurikam. Shodhan procedure has given a due importance in this disease by almost all acharyas. Among shodhan, Vaman & Virechan is indicated in Tamakshwas. This disease is manifested by aggrevated pranavayu due to obstruction of kapha. Acharya in case of Tamakshwas advices Vaman. The expression of bronchial asthma is influenced by the interaction between genetic,host & environmental factors.Apart from these there is going to be a large group of potential respiratory patients in future. They are person exposed to smoke, pollution & various types of occupational dust which are more prone to develop asthma & therefore constitute the group of potential respiratory patients. Drugs having kapha-vatahar property are indicated for Vaman Karma . Drugs having kapha-vataghna,ushna & vatanuloman activities will prescribed for Shwas. Avaleha kalpana described in Sharandhar Madhyamkhand . So I choose Shirishadi Avaleha,in which drugs having properties like kapha-vataghna,vatanuloman & shwashar. Hence,the present study is planned. |