| CTRI Number |
CTRI/2025/04/084798 [Registered on: 15/04/2025] Trial Registered Prospectively |
| Last Modified On: |
12/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Other (Specify) [NIL] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Add On Effect Of Marma Therapy Along With Murivenna Oil Local Application In Sprain |
|
Scientific Title of Study
|
Open Randomised Controlled Trial On Add On Effect Of Marma Chikitsa Along With Murivenna Taila Application In The Management Of Snayugata Vata With Special Reference To Sprain |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Majgaonkar Pradnya Tulshidas |
| Designation |
PG Scholar |
| Affiliation |
Government Ayurved College and Hospital, Nagpur |
| Address |
Department Of Shalyatantra OPD No 3, At Government Ayurved College and Hospital, Raje Raghuji Nagar, Sakkardara Square, Opposite Kamla Nehru Mahavidyalaya, Nagpur
Nagpur
MAHARASHTRA
440024
India |
| Phone |
9820148691 |
| Fax |
|
| Email |
pradnya.majgaonkar99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nita Kedar |
| Designation |
HOD and Professor |
| Affiliation |
Government Ayurved College and Hospital, Nagpur |
| Address |
Department Of Shalyatantra OPD No 3, At Government Ayurved College and Hospital, Raje Raghuji Nagar, Sakkardara Square, Opposite Kamla Nehru Mahavidyalaya, Nagpur
Nagpur
MAHARASHTRA
440024
India |
| Phone |
9422117613 |
| Fax |
|
| Email |
drnita6@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nita Kedar |
| Designation |
HOD and Professor |
| Affiliation |
Government Ayurved College and Hospital, Nagpur |
| Address |
Department Of Shalyatantra OPD No 3, At Government Ayurved College and Hospital, Raje Raghuji Nagar, Sakkardara Square, Opposite Kamla Nehru Mahavidyalaya, Nagpur
Nagpur
MAHARASHTRA
440024
India |
| Phone |
9422117613 |
| Fax |
|
| Email |
drnita6@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurved College and Hospital, Sakkardara Square, Nagpur, 440024 |
|
|
Primary Sponsor
|
| Name |
Majgaonkar Pradnya Tulshidas |
| Address |
At Government Ayurved College and Hospital, Raje Raghuji Nagar, Sakkardara Square, Opposite Kamla Nehru Mahavidyalaya, Nagpur, Maharashtra, India, 440024 |
| Type of Sponsor |
Other [[Self]] |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pradnya Tulshidas Majgaonkar |
Government Ayurved College and Hospital |
Department Of Shalyatantra OPD No 3, Government Ayurved College and Hospital, Raje Raghuji Nagar, Sakkardara Square, Opposite Kamla Nehru Mahavidyalaya, Nagpur, 440024
Nagpur
MAHARASHTRA |
9820148691
pradnya.majgaonkar99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Government Ayurved College and Hospital, Nagpur |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M958||Other specified acquired deformities of musculoskeletal system. Ayurveda Condition: SNAYUGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | marmacikitsA, मर्मचिकित्सा | (Procedure Reference: CCRAS- Marmachikitsa - Basic tenets in Ayurveda and Therapeutic approaches, Vd. K.S. Dhiman, Procedure details: Marma Chikitsa 16-18 times/ sitting along with Murivenna taila application 10 ml poured on roller bandage once a day for 7 days)
(1) Medicine Name: Murivenna Taila, Reference: Pharmacopoiea of Government Ayurvedic College Pharmacy, Trivandrum, Kerala; Ayurvedic Formulary of India third volume, Route: Topical, Dosage Form: Taila, Dose: 10(ml), Frequency: od, Duration: 7 Days | | 2 | Comparator Arm | Procedure | - | bandhanakarma, बन्धनकर्म | (Procedure Reference: Pharmacopoeia of Government Ayurvedic College Pharmacy, Trivandrum, Kerala; Ayurvedic Formulary of India third volume, Procedure details: Simple bandaging with gauze will be applied over affected joint for joint immobilization. Warm Murivenna taila approx. 10 ml will be poured on the roller bandage slowly once a day for 7 days.)
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients willing to participate in the study.
2. Patients of age group 18-60 years will be selected.
3. Patients will be randomly selected irrespective of sex, marital status, religion, educational status.
4. Patients with Pratyatmalakshana of Snayugata vata i.e. pain in the joint (Sandhishoola), swelling (Sandhishotha), tenderness (Sandhi pidanasahatva) and restricted movements of joint (Hanti Sandhigatoh).
5. Patients having traumatic history but not associated with fracture, dislocation and ligamental tear associated with Grade 2 and 3 sprain.
6. Patients suffering from Snayugata Vata (Grade 1 sprain) without any major illness.
7. Patients suffering from only upper or lower extremities joint sprain.
8. Co-operative patients.
9. Patients with controlled Diabetes Mellitus and blood pressure. |
|
| ExclusionCriteria |
| Details |
1. Patients not willing to participate in the study.
2. Patients of joint dislocation/ fracture or having the history of same.
3. Patients with Grade 2 and Grade 3 joint sprain.
4. Patients having previous history of ligament or bony reconstructive surgery to affected joint.
5. Patients presenting with wound over joint along with sprain.
6. Patients with congenital deformities of particular joint.
7. Immuno-compromised patients.
8. Non co-operative patients. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) To study the effect of Marma chikitsa along with Murivenna taila application in the management of Snayugata Vata with special reference to Sprain.
2) To study the effect of Murivenna taila application in the management of Snayugata Vata with special reference to Sprain.
3) To compare the effect of Murivenna taila application and add on effect of Marma Chikitsa along with Murivenna taila application in the management of Snayugata Vata with special reference to Sprain. |
Follow up on 8th day, 15th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the literature regarding Therapy and Disease through the Ayurvedic Texts and Modern Medical Science. |
Follow up on 8th day, 15th day |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
24/04/2025 |
| 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
|
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Brief Summary
|
After clearance from the Institutional Ethics Committee Government Ayurveda College and Hospital, Nagpur, screening of Population will be done from OPD, IPD and Casualty of our institute, 90 patients of Sprain will be included. If patients fulfill the criteria of inclusion, subject would also be given freedom to ask their questions and all questions would be answered. If he/she agrees for participation in study and found fit to include; the patient will be included in the study.
Study design: Open Label Randomised Controlled Trial
Study setting: The patients attending OPD and IPD of Shalyatantra Department of our Institute will be selected as subjects for this research study.
Study population: Patients attending OPD and IPD of Shalyatantra Department having signs and symptoms of "Snayugata Vata" will be selected.
Duration of study: 18 months after approval of synopsis
Duration of Treatment: 7 days
Sample Size
1) % Efficacy of Murivenna Taila = 50%
2) % Efficacy of Marma chikista with Murivenna Taila = 53%
3) Power (1 - beta)% = 80%
4) Alpha error %= 5%
Required sample size per group is 42.
Considering 10% dropout/ non-cooperative patients, final sample size is 45 per group.
MATCHING CRITERIA
A. Patients having age between 18-60 years.
B. Patients having clinical signs and symptoms of Snayugata Vata i.e. Sprain - Sandhishoola, Sandhishotha, Sandhi pidanasahatva and Hanti Sandhigotah.
DIAGNOSTIC CRITERIA
Clinical diagnosis will be done by assessing the presenting signs and symptoms:
Sandhishoola - Pain in the joint
Sandhishotha - Swelling over the joint
Sandhi pidanasahatva - Tenderness in the joint
Hanti sandhigatoh - Restricted movements of joint
Methods of Measurement:
Subjective Parameters
A) Local Pain (Shoola) Visual Analogue Scale (VAS) for pain
B) Restricted Movements of Joints ( Hanti sandhigatoh)
Objective Parameters
A) Local tenderness ( Sandhi pidanasahatva)
B) Local swelling ( Sandhishotha)
Clinical Investigations:
1.Complete Blood Count with Erythrocyte Sedimentation Rate
3.Blood Sugar Level: Fasting, Postprandial
Radiological Investigations:
X-ray of the affected joint (Left or Right) : ANTERO- POSTERIOR AND LATERAL VIEW
GROUP A: TRIAL GROUP - Marma Chikitsa along with Murivenna Taila application once a day for 7 days
GROUP B: CONTROL GROUP - Murivenna Taila application once a day for 7 Days
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