| CTRI Number |
CTRI/2023/03/050304 [Registered on: 03/03/2023] Trial Registered Prospectively |
| Last Modified On: |
02/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Other (Specify) [Yoga- Asana] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
TO FIND OUT THE EFFECT OF BHUJANGASANA AND PASHCHIMOTTANASANA IN THE PATIENTS OF AGNIMANDYA. |
|
Scientific Title of Study
|
A COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF BHUJANGASANA AND PASHCHIMOTTANASANA IN AGNIMANDYA. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vathsalya U S |
| Designation |
P.G Scholar |
| Affiliation |
Alvas Ayurveda Medical College and Hospital Moodubidire |
| Address |
P.G Scholar Department of P.G Studies in Swasthavritta and Yoga
Alvas Ayurveda Medical College and Hospital Moodubidire Dakshina Kannada Karnataka
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
8762142130 |
| Fax |
|
| Email |
vathsalyaus@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nagendra Kumar B C |
| Designation |
Professor and HOD |
| Affiliation |
Alvas Ayurveda Medical College and Hospital Moodubidire |
| Address |
Professor and HOD
Department of P.G Studies in Swasthavritta and Yoga
Alvas Ayurveda Medical College and Hospital Moodubidire Dakshina Kannada Karnataka
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9844471581 |
| Fax |
|
| Email |
nagendra.k18@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vathsalya U S |
| Designation |
P.G Scholar |
| Affiliation |
Alvas Ayurveda Medical College and Hospital Moodubidire |
| Address |
P.G Scholar Department of P.G Studies in Swasthavritta and Yoga
Alvas Ayurveda Medical College and Hospital Moodubidire Dakshina Kannada Karnataka
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
8762142130 |
| Fax |
|
| Email |
vathsalyaus@gmail.com |
|
|
Source of Monetary or Material Support
|
| Alvas Ayurveda Medical College and Hospital Moodubidire |
|
|
Primary Sponsor
|
| Name |
Dr Vathsalya U. S |
| Address |
P.G Scholar Department of P.G Studies in Swasthavritta and Yoga
Alvas Ayurveda Medical College and Hospital Moodubidire Dakshina Kannada Karnataka |
| 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 |
| Dr Vathsalya U S |
Alvas Ayurveda Medical College and Hospital Moodubidire |
Department of Swasthavritta and Yoga 4th floor Alvas Ayurveda Medical College and Hospital Moodubidire Dakshina Kannada
Dakshina Kannada
KARNATAKA |
8762142130
vathsalyaus@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical committee of Alvas Ayurveda Medical College and Hospital Moodubidire |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K30||Functional dyspepsia. Ayurveda Condition: MANDAGNIH/Â AGNISADA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Lifestyle | - | - | Dinacarya: NIL, Ritucarya: NIL, Acara Rasayana:NIL, Other:GROUP B - PASHCHMITTONASANA
-2 Sessions Morning and Evening in empty stomach
-4 rounds of YOGASANA in each session, Pathya/Apathya:no, Pathya:, Apathya: | | 2 | Comparator Arm | Lifestyle | - | - | Dinacarya: NIL, Ritucarya: NIL, Acara Rasayana:NIL, Other:GROUP A- BHUJANGASANA
2 sessions Morning and Evening in empty stomach
- 4 rounds of YOGASANA in each session, Pathya/Apathya:no, Pathya:, Apathya: |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Patients with signs and symptoms of AGNIMANDYA such as Udara gaurava Shiro gaurava Praseka Gatrasadana Kshudamandya |
|
| ExclusionCriteria |
| Details |
Patients suffering from any systemic illness.
Patients having any established pathology of gastrointestinal tract.
Pregnant and Lactating women |
|
|
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 |
| The effect of Asana in Agnimandya will be assessed based on detailed case proforma adopting scoring methods of subjective parameters such as Abhyavaharana shakti and Jarana shakti. |
Assessment will be done after 4 weeks and 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
06/03/2023 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a randomised comparative clinical study to evaluate the efficacy of Bhujangasana and Pashchimottanasana in Agnimandya for a duration of 30 days in 40 patients in OPD and IPD of Alvas Ayurveda Medical College, Alvas Educational campus, camps and other referrals. Assessment will be done based on detailed case proforma adopting scoring methods of subjective parameters. Pre and post assessement will be done. |