| CTRI Number |
CTRI/2019/11/021868 [Registered on: 05/11/2019] Trial Registered Prospectively |
| Last Modified On: |
04/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Yoga & Naturopathy
Diagnostic
Other (Specify) [Nadi Sweda] |
| Study Design |
Other |
|
Public Title of Study
|
EFFECT OF AYURVEDIC DRUG, FOMENTATION AND LOCAL STEAM BATH IN JOINT DISORDER |
|
Scientific Title of Study
|
A COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFECT OF DASHMOOL KWATH NADI SWEDA AND LOCAL STEAM BATH IN SANDHI-GATA-VATA |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Namita patel |
| Designation |
M D Scholar Depatment of Swasthavritta and Yoga |
| Affiliation |
NIA Jaipur |
| Address |
ROOM NO 21
Swasthvritta OPD
National Institute of Ayurveda
Madho vilas palace
Amer road Jaipur Rajasthan
ROOM NO 21
Swasthvritta OPD
National institute of Ayurveda
Madho vilas palace
Amer road
Jaipur Rajasthan
Jaipur
RAJASTHAN
302002
India |
| Phone |
09617980439 |
| Fax |
|
| Email |
namita03302@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Durgawati Devi |
| Designation |
Associate Prof Depatment of Swasthavrrita and Yogaitta and Yoga |
| Affiliation |
NIA Jaipur |
| Address |
Dept of Swasthavritta and Yoga National Institute of Ayurveda Madho vilas palace Amer road Jaipur Rajasthan
Jaipur
RAJASTHAN
302002
India |
| Phone |
9929564660 |
| Fax |
|
| Email |
dvd6197@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Durgawati Devi |
| Designation |
Associate Prof Depatment of Swasthavrrita and Yogaitta and Yoga |
| Affiliation |
NIA Jaipur |
| Address |
Room no 21
Swasthavritta and Yoga OPD
National Institute of Ayurveda Madho vilas palace Amer road Jaipur Rajasthan
Jaipur
RAJASTHAN
302002
India |
| Phone |
9929564660 |
| Fax |
|
| Email |
dvd6197@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute Of Ayurveda
jorawar singh gate
Amer Road
Jaipur 302002 |
|
|
Primary Sponsor
|
| Name |
National Institute Of Ayurveda Jaipur |
| Address |
Near Jorawar Singh Gate Amer Road Jaipur 302002 |
| Type of Sponsor |
Government 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 |
| Namita patel |
National Institute Of Ayurveda,Jaipur |
National Institute of Ayurveda
Room No 21
Swasthvritta and Yoga OPD
Madho vilas palace
Amer road
Jaipur 302002
Rajasthan.
Jaipur
RAJASTHAN |
09617980439
namita03302@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee National Institute of Ayurveda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M154||Erosive (osteo)arthritis, (2) ICD-10 Condition: M159||Polyosteoarthritis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Yogaraj guggulu
Local steam bath |
Group B will be administered with Yogaraja-2 tab. TDS And Local steam bath for 15-20 min. on affected joint/joints twice a day |
| Intervention |
Yogaraj guggulu
Nadi Sweda of Dashmool Kawath |
Group A will be Administered with Yogaraj Guggulu- 2 tab TDS And Nadi Sweda of Dashmool Kawath for15-20 min. on affected joint/joints after application of Dashmool tail twice a day. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients beyond 18 years of age of either sex will be included.
2.Patients having complaint of single or multiple joint pain.
|
|
| ExclusionCriteria |
| Details |
1 History of trauma /injury/tumor/ infection and non-mechanical cause.
2 Patients ofAmavata,Vataraktaand involvement of pittaor RaktaDosha.
3 Hypertension,heart disease, diarrhea.
4 Pregnancy, lactation andduring menstruation.
5 Chronic and systemic aliment or any anatomical condition.
6 Disc herniation of vertebral column.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| TO EVALUATE THE EFFECT OF DASHMOOL KWATH NADI SWEDA AND LOCAL STEAM BATH IN SANDHI-GATA-VATA. |
3 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Any advers event reported voluntarily,oberved or enquired.Recurrence in sign and symptomsof Sandhigatavata |
3 month |
|
|
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 |
|
Date of First Enrollment (India)
|
10/11/2019 |
| 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
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study will be a comparative clinical phase 2 trial.The screen patients will be randomly divided in two group using computerized randomization method for unbiased allocation.
1. Group A will be given - ( a) Yogaraj guggulu - 2 tab. TDS ( b) Nadi Sweda of Dashmool Kawath for 15-20 min.on affected joint after application of Dashmool tail twice a day 2. Group b will be given - ( a) Yogaraj guggulu - 2 tab TDS ( b) Local steam bath for 15-20 min on affected joint twice a day. Aim and objectives:
To compare the effect between Nadi Sweda and local steam bath therapy in Sandhi-Gata-Vata
|