| CTRI Number |
CTRI/2025/02/079986 [Registered on: 06/02/2025] Trial Registered Prospectively |
| Last Modified On: |
31/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparative Study Of Marma Chikitsa And Rasna Kwath In the Pain Managment Of Janu Sandhigatvat
( Osteoarthritis) |
|
Scientific Title of Study
|
comparative study of marma chikistsa and rasna kwath in pain management of janu sandhigatvata(osteoarthritus) |
| 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 Pallavi Waghmare |
| Designation |
MD Scholar Rachna Sharir |
| Affiliation |
Pt Khushilal Sharma Govt(Auto) Ayurveda College And Institute Bhopal Madhya Pradesh |
| Address |
PG Department Of Rachna Sharir Pt Khushilal Sharma Govt(Auto) Ayurveda College And Institute
Bhopal(462003) Madhya Pradesh (India)
PG Department Of Rachna Sharir Pt Khushilal Sharma Govt(Auto) Ayurveda College And Institute
Bhopal(462003) Madhya Pradesh( India)
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
07049207334 |
| Fax |
|
| Email |
pallaviwaghmare2296@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shiba Datta Panda |
| Designation |
Lecturer Department Of Rachna Sharir |
| Affiliation |
Pt Khushilal Sharma Govt(Auto) Ayurveda College And Institute Bhopal Madhya Pradesh |
| Address |
PG Department Of Rachna Sharir Pt Khushilal Sharma Govt(Auto) Ayurveda College And Institute
Bhopal Madhya Pradesh ( India)
PG Department Of Rachna Sharir Pt Khushilal Sharma Govt(Auto) Ayurveda College And Institute
Bhopal Madhya Pradesh( India)
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
07089204120 |
| Fax |
|
| Email |
panda.guru@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pallavi Waghmare |
| Designation |
MD Scholar Rachna Sharir |
| Affiliation |
Pt Khushilal Sharma Govt (Auto) Ayurveda College And Institute Bhopal Madhya Pradesh |
| Address |
PG Department Of Rachna Sharir Pt Khushilal Sharma Govt (Auto) Ayurveda College And Institute
Bhopal Madhya Pradesh
PG Department Of Rachna Sharir Pt Khushilal Sharma Govt (Auto) Ayurveda College And Institute
Bhopal Madhya Pradesh
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
7049207334 |
| Fax |
|
| Email |
pallaviwaghmare2296@gmail.com |
|
|
Source of Monetary or Material Support
|
| PG Department Of Rachna Sharir Pandit Khushilal Sharma Govt (Auto) Ayurveda College And
Institute Bhopal Madhya Pradesh 462003 |
|
|
Primary Sponsor
|
| Name |
Pt Khushilal Sharma Govt (Auto) Ayurveda College And Institute Bhopal Madhya Pradesh |
| Address |
PG Department Of Rachna Sharir Pt Khushilal Sharma Govt (Auto)
Ayurveda College And Institute Bhopal Madhya Pradesh |
| 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 Pallavi waghmare |
Pt Khushilal Sharma Govt (Auto) Ayurveda College And Institute Bhopal Madhya Prades |
PG Department Of
Rachna Sharir Pt
Khushilal Sharma Govt
(Auto) Ayurveda
College And Institute
Bhopal Madhya
Pradesh
Bhopal
MADHYA PRADESH
Bhopal
MADHYA PRADESH |
07049207334
pallaviwaghmare2296@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Pt. Khushilal Sharma Government Ayurveda Institute,Bhopal (M.P.) |
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: SANDHIGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | marmacikitsA, मर्मचिकित्सा | (Procedure Reference: DR.S.K.Joshi, Procedure details: marma chikita done 15- 18 times with 0.8 sec of stimuli for 15days.
)
| | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Rasna (Pluchea Lanceolata ), Reference: Charak sutra 25, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 30(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: No |
|
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. The patients between the age 35 to 60 years .
2. Patients of either sex having clinical feature of osteoarthritis.
3. Patients with Primary osteoarthritis of knee joints (single or both knees)
4. Kellgren Lawrence (Radiological scale ) of grade one without structural deformity. |
|
| ExclusionCriteria |
| Details |
1. Patients with systemic conditions such as Gouty Arthritis, Rheumatoid Arthritis, psoriatic arthritis.
2. Patients with Diabetes Hypertension
3. Patients using local Anti-inflammatory medicine other than the research drugs.
4. Low backache with or without radiation to legs. |
|
|
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
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
It is expected that at the end of study, scholar will be able to evaluate the effect of Marma Chikitsa and
rasna kwath in the pain management of Janusandhigatavata. |
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| it is cost effective and gives instant relief in pain |
15 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
16/02/2025 |
| 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
|
In Jaravasta , all Dhatus undergo Kshaya , thus leading to Vataprakopa and making individual prone to Sandhigatvata . Rasna has been traditionally used since ancient times by Ayurvedic practitioner , to treat various painful condition and swelling of the joint. It is major ingredient of famous anti-inflammatory Ayurvedic decoction.marma chikitsa play major role in treatment of pain management .so with this study scholar will prove the efficacy of marma chikitsa in the manangement of Osteoarthritis. |