| CTRI Number |
CTRI/2025/06/089414 [Registered on: 24/06/2025] Trial Registered Prospectively |
| Last Modified On: |
24/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Other (Specify) [Marma chikitsa and Dhanwantara taila abhyanga] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Marma chikitsa in Frozen Shoulder |
|
Scientific Title of Study
|
A comparative study on efficacy of marma chikitsa and sthanika abhyanga with dhanwantara taila in the management of frozen shoulder |
| Trial Acronym |
RCT |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nilamadhaba Majhi |
| Designation |
MD Scholar Dept. of Rachana Sharir |
| Affiliation |
Pt Khushilal Govt Auto Ayurveda College and Institute Bhopal |
| Address |
PG Department of Rachana Sharir Pt Khushilal Govt Auto Ayurveda College and Institute Bhopal
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
8327791636 |
| Fax |
|
| Email |
nilamadhabamajhi5516@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rita Marwaha |
| Designation |
Prof. and HOD Dept. of Rachana Sharir |
| Affiliation |
Pt Khushilal Govt Auto Ayurveda College and Institute Bhopal |
| Address |
PG Department of Rachana Sharir Pt Khushilal Govt Auto Ayurveda College and Institute Bhopal
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
9425679777 |
| Fax |
|
| Email |
marwaharita@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrNilamadhaba Majhi |
| Designation |
MD Scholar Dept. of Rachana Sharir |
| Affiliation |
Pt Khushilal Govt Auto Ayurveda College and Institute Bhopal |
| Address |
PG Department of Rachana Sharir Pt Khushilal Govt Auto Ayurveda College and Institute Bhopal
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
8327791636 |
| Fax |
|
| Email |
nilamadhabamajhi5516@gmail.com |
|
|
Source of Monetary or Material Support
|
| PG Department of Rachana Sharira
Pt.KLS Govt.(auto.) ayurveda college and institute,Bhopal Madhya Pradesh 462003 |
|
|
Primary Sponsor
|
| Name |
PG Department of Rachana Sharir |
| Address |
Pt Khushilal Govt Auto Ayurveda College and Institute Bhopal Madhya Pradesh 462003 |
| Type of Sponsor |
Government funding agency |
|
|
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 Nilamadhaba Majhi |
Pt Khushilal Govt Auto Ayurveda College and Institute Bhopal |
PG Department of Rachana Sharir Pt Khushilal Govt Auto Ayurveda College and Institute Bhopal
Bhopal
MADHYA PRADESH |
8327791636
nilamadhabamajhi5516@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC,Pt.kls govt ayurveda college and institute,Bhopal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M255||Pain in joint. Ayurveda Condition: AVABAHUKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | Marma Chikitsa and Abhyanga | (Procedure Reference: , Procedure details: For marma chikitsa-15 to 18 times marma sthana stimutation with frequency of 0.8sec./per days for 15 days.For Abhyanga 15-20 times/per days with dhanwantara taila)
| | 2 | Comparator Arm | Procedure | - | marmacikitsA, मर्मचिकित्सा | (Procedure Reference: , Procedure details: Marma Chikitsa & Sthanika Abhyanga once in a day for 15 days)
|
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients of either sex presenting with symptoms of frozen shoulder as mention in diagnostic criteria.
2.Patients age between 20-70 years.
3.Patients who wish to sign the written consent to participate in the study. |
|
| ExclusionCriteria |
| Details |
1.Pregnant women and lactating mother.
2.Patients suffering from shoulderjoint arthritis.
3.Patients who needs surgical care or have undergone any surgical intervention.
4.Patients having fracture or dislocation in the shoulder joint.
5.Patients having systemic illness.
6.Patients having NSAIDs and steroid will be considered for enrollment on withdrawal after one months of enrollment. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| It Is Expected That At The End Of The Study We Will Be Abled To Evaluate The Effect Of The Marma Chikitsa And Sthanika Abhyanga In The Management Of Frozen Shoulder |
15 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Marma Chikitsa Is A Non-pharmaceutical Approach For The Management Of Frozen Shoulder |
15 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
|
N/A |
|
Date of First Enrollment (India)
|
30/07/2025 |
| 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 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
|
The study compares the effectiveness of two Ayurvedic treatments for the management of frozen shoulder. Treatment Groups- Group 1 Marma Chikitsa- 20 patients of this group will be treated with Marma Chikitsa once a day for 15 days,The treatment involve specific pressure on Marma sthana . Group 2 Sthanika abhyanga -20 patients of this group will be treated with Dhanwantara taila once aday for 15 days. Expected Outcome- The study aims to determine which treatment is more effective in the management of frozen shoulderr Possible Results- Marma Chikitsa more effective If Group 1 shows significant improvement in the symptomsof frozen shoulder compared to Group 2. Sthanika abhyanga more effective If Group 2 shows significant improvement in the symptoms of frozen shoulder compared to Group 1. The study finding will help to determine the most suitable treatment approach for the management of frozen shoulder. |