| CTRI Number |
CTRI/2025/12/099653 [Registered on: 22/12/2025] Trial Registered Prospectively |
| Last Modified On: |
22/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
A study to find out whether the intake of beef bone marrow processed in some Ayurvedic medicines as shamana snehapana helps to reduce knee pain and joint problems. |
|
Scientific Title of Study
|
A Clinical Trial On The Effect Of Shamana Snehapana With Dasamooladi Siddha Majja In Osteoarthritis Of Knee |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MEGHA K |
| Designation |
PG Scholar ,Department of Panchakarma |
| Affiliation |
Government Ayurveda College Tripunithura |
| Address |
Second year PG Scholar, Department of Panchakarma, Government Ayurveda College, Tripunithura, Ernakulam,Kerala,682301,India
Ernakulam
KERALA
682301
India |
| Phone |
9562726504 |
| Fax |
|
| Email |
drmeghak98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Remya Vijayan |
| Designation |
Associate Professor |
| Affiliation |
Government Ayurveda College Tripunithura |
| Address |
Associate Professor, Department of Panchakarma, Government Ayurveda College, Tripunithura, Ernakulam, Kerala, 682301
Ernakulam
KERALA
682301
India |
| Phone |
9847852619 |
| Fax |
|
| Email |
dr.remyavijayan83@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Remya Vijayan |
| Designation |
Associate Professor |
| Affiliation |
Government Ayurveda College Tripunithura |
| Address |
Associate Professor, Department of Panchakarma, Government Ayurveda College, Tripunithura, Ernakulam, Kerala, 682301
Ernakulam
KERALA
682301
India |
| Phone |
9847852619 |
| Fax |
|
| Email |
dr.remyavijayan83@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurveda College Tripunithura,Ernakulam, kerala-682301 |
|
|
Primary Sponsor
|
| Name |
Government Ayurveda College, Tripunithura |
| Address |
Government Ayurveda College, Tripunithura, Puthiyakavu Ernakulam
Pincode : 682301 |
| Type of Sponsor |
Other [Government Ayurveda College ,Tripunithura] |
|
|
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 Remya Vijayan |
Government Ayurveda College and Hospital, Tripunithura |
Department of Panchakarma IPD,OPD number-5
Ernakulam
KERALA |
9847852619
dr.remyavijayan83@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee(IEC)Government Ayurveda College,Tripunithura, Kochi, Kerala-682301 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M179||Osteoarthritis of knee, unspecified. Ayurveda Condition: VATAVYADHIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Dasamooladi siddha majja, Reference: chakradatta, Route: Oral, Dosage Form: Ghrita, Dose: 10(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 9 Days, anupAna/sahapAna: Yes(details: mandam), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Participants among age group 40-60 years satisfying diagnostic criteria
2)Participants willing to give written consent
3)Participants fit for snehapana
4)Participants willing to take medicines prepared from animal source(beef) |
|
| ExclusionCriteria |
| Details |
1)Uncontrolled case of systemic illness
2)History of recent fracture/dislocation in and around the knee joint
3)Presence of wound or ulcer in and around and with inflammatory swelling of the knee joint
4)Pregnant and lactating woman.
5)Rheumatoid arthritis of knee, neoplasms, congenital deformities of knee
6)Diagnosed case of diabetes mellitus
7)Diagnosed case of hypercholesterolemia
8)Diagnosed case of hypertension
9)Participants allergic to beef products |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in score of variables in WOMAC criteria |
0th day 10th day 28th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Pain assessed by visual analogue scale
2. Range of movements of knee joint using goniometry
3. Samyak snigdha lakshana are assessed by grading
4. Assessment of liver function test and lipid profile |
0th and 10th day |
|
|
Target Sample Size
|
Total Sample Size="27"
Sample Size from India="27"
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 3 |
|
Date of First Enrollment (India)
|
02/01/2026 |
| 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 this study dasamooladi siddha majja sneha mentioned in chakradatta vata vyadhi adhyaya is used in the form of shamana snehapana.The mahisha majja processed with dasamoola kashaya,milk,jeevaniya gana,vidari,kapikachu,sariba and administered in patients with osteoarthritis of knee .This study intend to evaluate the effect of dasamooladi siddha majja as shamana snehapana in reducing the signs and symptoms of osteoarthritis of knee joint |