| CTRI Number |
CTRI/2023/06/054374 [Registered on: 23/06/2023] Trial Registered Prospectively |
| Last Modified On: |
22/06/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Preventive
Physiotherapy (Not Including YOGA) |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
A comparative study on Abhyanga- oil massage and physiotherapy in the management of Osteoarthrities |
|
Scientific Title of Study
|
A comparative/interventional effect study of Abhyanga and Abhyanga with Physiotherapy in sandhigatavata |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anagha Mathad |
| Designation |
Assistant Professor |
| Affiliation |
Parul Institute of Ayurveda nd Research, |
| Address |
Parul Institute of Ayurveda nd Research, Ishwarapura, waghodia road, vadodara,Gujurat
Parul Institute of Ayurveda nd Research, Ishwarapura, waghodia road, vadodara,Gujurat
Vadodara
GUJARAT
391760
India |
| Phone |
9449394048 |
| Fax |
9449394048 |
| Email |
anu.as.anagha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anagha Mathad |
| Designation |
Assistant Professor |
| Affiliation |
Parul Institute of Ayurveda nd Research, |
| Address |
Parul Institute of Ayurveda nd Research, Ishwarapura, waghodia road, vadodara,Gujurat
Parul Institute of Ayurveda nd Research, Ishwarapura, waghodia road, vadodara,Gujurat
Vadodara
GUJARAT
391760
India |
| Phone |
9449394048 |
| Fax |
9449394048 |
| Email |
anu.as.anagha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anagha Mathad |
| Designation |
Assistant Professor |
| Affiliation |
Parul Institute of Ayurveda nd Research, |
| Address |
Parul Institute of Ayurveda nd Research, Ishwarapura, waghodia road, vadodara,Gujurat
Parul Institute of Ayurveda nd Research, Ishwarapura, waghodia road, vadodara,Gujurat
Vadodara
GUJARAT
391760
India |
| Phone |
9449394048 |
| Fax |
9449394048 |
| Email |
anu.as.anagha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Parul Institute of Ayurved and research |
|
|
Primary Sponsor
|
| Name |
Khemdas Ayurved Hospital |
| Address |
Parul Institute of Ayurveda nd Research, Ishwarapura, waghodia road, vadodara,Gujurat |
| 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 Anagha Mathad |
Khemadas Ayurved Hospital |
Teaching Institute of Parul Institute of Ayurved and research, Ishwarapura, Limda, Waghodia
Vadodara
GUJARAT |
9449394048
anu.as.anagha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PIAR-HR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M170||Bilateral primary osteoarthritis of knee. Ayurveda Condition: sandhivata, (2) ICD-10 Condition:M170||Bilateral primary osteoarthritis of knee. Ayurveda Condition: SANDHIGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | aBya~ggaH, अà¤à¥à¤¯à¤‚ग | (Procedure Reference: Charaka Samhita, Procedure details: 20 minutes of massage externally in effected site)
(1) Medicine Name: Murchita tila taila, Reference: Bhaishajya ratnavali, Route: Topical, Dosage Form: Taila, Dose: 20(ml), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
primary oesteo knee arthritis |
|
| ExclusionCriteria |
| Details |
injury, trauma, operated knee osteoarthritis |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| the effect of abhyanga with or without physiotherapy in knee osteoarthritiscan be known which help further plan for the management of sandhivata |
the effect of abhyanga with or without physiotherapy in knee osteoarthritiscan be known which help further plan for the management of sandhivata |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Relief from pain
movement of limb |
3 days from date of administration |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
N/A |
|
Date of First Enrollment (India)
|
05/07/2023 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
An Interventional- Observational study between Abhyanga- medicated oil massage with physiotherapy and only Abhyanga in the management of knee osteoarthrities. these two therapies advised as composite treatment hence to know their efficacy, this study is planned. |