| CTRI Number |
CTRI/2025/02/080892 [Registered on: 19/02/2025] Trial Registered Prospectively |
| Last Modified On: |
18/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Preventive
Other (Specify) [External procedure] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the effectiveness of Udvartana in managing pain produced after Vyayama in Sthula. |
|
Scientific Title of Study
|
CLINICAL EVALUATION OF EFFECTIVENESS OF UDVARTANA IN MANAGING PAIN INDUCED DUE TO VYAYAM IN STHULA(OVERWEIGHT/OBESE). |
| 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 Adithi B |
| Designation |
PG Scholar Department of Swasthavritta |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda andHospital |
| Address |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Thanniruhalla B M Road Hassan
Hassan
KARNATAKA
573201
India |
| Phone |
9447654298 |
| Fax |
- |
| Email |
pg23151@sdmcahhassan.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M B Kavita |
| Designation |
Professor and Head of the department Department of swasthavritta |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
| Address |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Thanniruhalla B M Road Hassan
Hassan
KARNATAKA
573201
India |
| Phone |
9447654298 |
| Fax |
- |
| Email |
drmbkavita@sdmcahhassan.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Adithi B |
| Designation |
PG Scholar Department of Swasthavritta |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
| Address |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Thanniruhalla B M Road Hassan
Hassan
KARNATAKA
573201
India |
| Phone |
9447654298 |
| Fax |
- |
| Email |
pg23151@sdmcahhassan.org |
|
|
Source of Monetary or Material Support
|
| Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Thanniruhalla B M Road Hassan
Karnataka, India
573201
college@sdmcahhassan.org |
|
|
Primary Sponsor
|
| Name |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
| Address |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Thanniruhalla B M Road Hassan Karnataka 573201 college@sdmcahhassan.org |
| Type of Sponsor |
Private medical college |
|
|
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 Adithi B |
INSTITUTIONAL ETHICS COMMITTEE Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Thanniruhalla B M Road Hassan Karnataka, India
573201
college@sdmcahhassan.org
Hassan
KARNATAKA |
9447654298
pg23151@sdmcahhassan.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Thanniruhalla B M Road Hassan Karnataka 573201 college@sdmcahhassan.org |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E663||Overweight. Ayurveda Condition: MEDOROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | udvartanam, उद्वर्तनम् | (Procedure Reference: Srikantha Murthy, Sushruta Samhitha, Cikitsa Sthana Adhyaya 24/51, Chaukhambha Orientalia, Varanasi, 2012, 228, Procedure details: Poorva karma
Udvartana will be done after evacuating the bowel & bladder. Subject wearing minimum clothing is advised to lie down on the massage table.
Pradhana karma
Udvartana will be done on each part of the body below the neck by exerting some pressure.
Pashchat karma
Subject will be advised to take rest for at least 5 minutes & then will be allowed to take bath with lukewarm water.
Duration of Udvartana
Each part of the body in their respective positions will be massaged for 3-5 minutes. The duration of Udvartana will be 30-45 minutes.
)
| | 2 | Comparator Arm | Lifestyle | - | - | Dinacarya: vyayama, Ritucarya: , Acara Rasayana:, Other:, Pathya/Apathya:, Pathya:, Apathya: |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects with BMI 23 to 39.9 kg m2, who don’t practice exercise regularly.
2. Subjects who experience body pain after vyayama and with Defense and Veterans pain rating scale (DVPRS)equal to or greater than 03.
3. Subjects aged between 25 to 50 years irrespective of the gender occupation and socio-economic status.
4.Subjects who are fit for udvartana
|
|
| ExclusionCriteria |
| Details |
1. Subjects who are on regular analgesic medication.
2. Subjects with impaired mobility.
3. Subjects who are unfit for Vyayama.
4. Subjects who can’t follow the instructions given
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To study the effectiveness of udvartana in preventing pain given before vyayama on subjects with pain induced due to vyayama.
2. To study the effectiveness of udvartana in alleviating pain given after vyayama on subjects with pain induced due to vyayama.
3. To compare the effectiveness of udvartana given pre and post vyayama on subjects with pain induced due to vyayama in order to ascertain the best sequence.
|
5 DAYS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. BMI before and after the intervension.
|
5 DAYS |
|
|
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)
|
01/03/2025 |
| 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 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
|
CLINICAL
EVALUATION OF EFFECTIVENESS OF UDVARTANA IN MANAGING PAIN
INDUCED DUE TO VYAYAMA IN STHULA. A 5 days
clinical trail with 40 patients. 20 in each group namely study group and
comparative group. Patients diagnosed using BMI, Brocas index and Waist hip
ratio filtered after inclusion and exclusion criteria will be selected for the
study. Intervention include an external procedure named Udavartana given before
vyayama in one group and after vyayama in other. Pain induced due to
vyayama and after udvatana will be assessed using Defense and Veterans
Pain Rating Scale and Likert scale for muscle soreness and noted. The date
with be then analysed using statistical software. |