| CTRI Number |
CTRI/2025/09/094169 [Registered on: 03/09/2025] Trial Registered Prospectively |
| Last Modified On: |
03/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [basti procedure] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Asthishrinkhala and Ashwagandha sidha ksheer matra basti in the management of Janu sandhigatavata. |
|
Scientific Title of Study
|
A Comparative clinical study on the effect of Asthishrinkhala sidha ksheer matra basti & Ashwagandha sidha ksheer matra basti in the management of Janu sandhigata vata w.s.r. to osteoarthritis of knee joint |
| 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 PRAVEEN BHAGAT |
| Designation |
Pg scholar Department of panchkarma |
| Affiliation |
Rani Dullaiya Smriti Ayurved PG College And Hospital Barkhedi Kalan Bhadbhada Road Bhopal |
| Address |
Department of panchkarma, opd no.5,Rani Dullaiya Smriti Ayurved PG College And Hospital Barkhedi Kalan Bhadbhada Road, Bhopal
Bhopal
MADHYA PRADESH
462044
India |
| Phone |
9179666562 |
| Fax |
|
| Email |
bhagatpk23@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Atul Pawar |
| Designation |
H.O.D. & Professor In Panchkarma |
| Affiliation |
Rani Dullaiya Smriti Ayurved PG College And Hospital Barkhedi Kalan Bhadbhada Road Bhopal |
| Address |
Department of panchkarma ,opd no.5,Rani Dullaiya Smriti Ayurved PG College And Hospital, Barkhedi Kalan Bhadbhada Road, Bhopal
Bhopal
MADHYA PRADESH
462044
India |
| Phone |
7499055336 |
| Fax |
|
| Email |
atul84pawar.ap.ap@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Atul Pawar |
| Designation |
H.O.D. & Professor In Panchkarma |
| Affiliation |
Rani Dullaiya Smriti Ayurved PG College And Hospital Barkhedi Kalan Bhadbhada Road Bhopal |
| Address |
Department of panchkarma ,opd no.5,Rani Dullaiya Smriti Ayurved PG College And Hospital, Barkhedi Kalan Bhadbhada Road, Bhopal
Bhopal
MADHYA PRADESH
462044
India |
| Phone |
7499055336 |
| Fax |
|
| Email |
atul84pawar.ap.ap@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pg Department of panchkarma,opd no.5, Rani Dullaiya Smriti Ayurved PG College And Hospital Barkhedi Kalan Bhadbhada Road, Bhopal |
|
|
Primary Sponsor
|
| Name |
Dr Praveen Bhagat |
| Address |
Pg Department of panchkarma,opd no.5, Rani Dullaiya Smriti Ayurved PG College And Hospital Barkhedi Kalan Bhadbhada Road, Bhopal |
| Type of Sponsor |
Other [self] |
|
|
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 Praveen Bhagat |
Rani dullaiya smriti ayurved Pg college & Hospital ,Bhopal, Madhya Pradesh , India ,462044 |
Department of Panchkarma , O.P.D. NO. 05, Rani Dullaiya Smriti Ayurved PG College And Hospital Barkhedi Kalan Bhadbhada Road Bhopal
Bhopal
MADHYA PRADESH |
9179666562
bhagatpk23@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Rani Dullaiya Smriti Ayurved PG College And Hospital Bhopal MP |
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: SANDHIGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: ASTHISHRINKHALA, Reference: BHAVPRAKASH, Route: Rectal, Dosage Form: Ksheerpaka, Dose: 120(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 16 Days, anupAna/sahapAna: No, Additional Information: Asthishrinkhala siddha ksheer matra basti will be given | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Ashwagandha , Reference: Bhavprakash Nighantu, Route: Rectal, Dosage Form: Ksheerpaka, Dose: 120(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 16 Days, anupAna/sahapAna: No, Additional Information: Ashwagandha siddha ksheer matra basti will be given |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients having signs and symptoms of Janu Sandhigata Vata explained in Ayurveda texts.
Patients will be selected irrespective of caste and religion, gender, habitat, occupation and Socio-
economic status.
|
|
| ExclusionCriteria |
| Details |
Pregnant Women and lactating mothers.
Patients who are known case of any types of malignancy, chronic renal failure, acute illness like CVA,etc.
Severe Hypertension and Hormone imbalance.
Patients who are known case of Rheumatoid Arthritis (RA), Gout, T.B. of Knee Joints, Traumatic
Osteoarthritis of knee etc . |
|
|
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 |
| Reduce in symptoms like the pain,shotha,knee pain , knee stiffness,Prasarana akunchanayoh pravarttishch savedana(pain during flexion and extension) will be seen. |
16 DAYS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Marked improvement in symptoms like the pain,shotha,knee pain , knee stiffness,Prasarana akunchanayoh pravarttishch savedana(pain during flexion and extension) will be seen alongwith decrease in reading of VAS( VISUAL ANALOGUE SCALE). |
16 DAYS |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
22/09/2025 |
| 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="0"
Months="11"
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
|
Prevalence of symptomatic osteoarthritis in India 22% to 39% of common population.Overall prevalence of knee OA was found to be 28.7%.The need for a satisfactory treatment regimen in modern medicine is indeed crucial, especially for conditions like osteoarthritis whsere conventional treatments such as analgesics, anti-inflammatory drugs, and surgeries may not always provide adequate relief and can carry significant adverse effects. Ayurvedic treatments, as mentioned in ancient Ayurvedic texts, offer an alternative approach that is claimed to be effective and safe for managing osteoarthritis. Exploring Ayurvedic therapies alongside conventional treatments could provide additional options for patients seeking relief with potentially fewer side effects. Further research and integration of Ayurvedic principles into modern healthcare practices could offer promising avenues for improving outcomes in osteoarthritis management. A COMPARATIVE CLINICAL STUDY ON THE EFFECT OF ASTHISHRINKHLA SIDDHA KSHEER MATRA BASTI ANDASHWAGANDHA SIDDHA KSHEER MATRA BASTI IN THE MANAGEMENT OF JANU SANDHIGATA VATA W.S.R. TO OSTEOARTHRITIS OF KNEE JOINTS.in this study researcher will prepare ASTHISHRINKHALA SIDDHA KSHEER MATRA BASTI as per classical reference.objectives of the study will be to assess the reduction in cardinal signs of JANUSANDHIGATAVATA i.e.Vatapoorna Driti Sparshah, Shotha, Prasarana Akunchanayoh Pravrattishch ,Savedana (Pain during flexion and extension), Knee Pain,Knee Stiffness.To assess the reduction in score before and after treatment in the following criteria .Vatapoorna Driti Sparshah, Shotha, Prasarana Akunchanayoh Pravrattishch ,Savedana (Pain during flexion and extension), Knee Pain,Knee Stiffness Exclusion and inclusion criteria are taken . |