| CTRI Number |
CTRI/2026/03/106736 [Registered on: 23/03/2026] Trial Registered Prospectively |
| Last Modified On: |
20/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Shatpushpadi lepa and Janubasti with Murchit til tail on Janusandhigata vata w.s.r to Osteoarthritis of Knee joints |
|
Scientific Title of Study
|
A clinical study to evaluate the Effect of Shatpushpadi lepa and Janubasti with Murchit til tail on Janusandhigata vata w.s.r to Osteoarthritis of Knee joints |
| 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 Anju Kumari |
| Designation |
MD(Ay.) Scholar (Panchakarma) |
| Affiliation |
Government Ayurvedic College and Hospital Kadamkuan Patna Bihar |
| Address |
Department of Panchakarma Government Ayurvedic College and Hospital near budhmurti Kadamkuan Patna
Patna BIHAR 800003 India |
| Phone |
8789513266 |
| Fax |
|
| Email |
anju.pandit92@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Prof Satyendra Kumar Tiwari |
| Designation |
H.O.D Professor Department of Panchakarma |
| Affiliation |
Government Ayurvedic College and Hospital Kadamkuan Patna Bihar |
| Address |
Department of Panchakarma Government Ayurvedic College and Hospital near budhmurti Kadamkuan Patna
Patna BIHAR 800003 India |
| Phone |
9024064735 |
| Fax |
|
| Email |
satyendratiwari.25@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Prof Satyendra Kumar Tiwari |
| Designation |
H.O.D Professor Department of Panchakarma |
| Affiliation |
Government Ayurvedic College and Hospital Kadamkuan Patna Bihar |
| Address |
Department of Panchakarma Government Ayurvedic College and Hospital near budhmurti Kadamkuan Patna
Patna BIHAR 800003 India |
| Phone |
9024064735 |
| Fax |
|
| Email |
satyendratiwari.25@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurvedic College and Hospital,
near Budhmurti Kadamkuan,
Patna,
Bihar
PIN - 800003 |
|
|
Primary Sponsor
|
| Name |
Dr Anju Kumari |
| Address |
Department of Panchakarma Government Ayurvedic College and Hospital near Budhmurti Kadamkuan Patna
BIHAR
PIN 800003 |
| 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 Anju Kumari |
Government Ayurvedic College and Hospital |
OPD Room number 11 /IPD Department Of Panchkarma Government Ayurvedic College and Hospital near Budhmurti Kadumkuan Patna 800003 Patna BIHAR |
8789513266
anju.pandit92@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional dethical comitee |
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: JANUBEDAH (KEVALAVATA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | lepa, लेप | (Procedure Reference: YOGRATNAKAR, Procedure details: LEPA OF SHATPUSHPADI CHURN WILL BE APPLIED ON THE PATIENT OF JANUSANDHIGAT VATA FOR 15 DAYS)
| | 2 | Intervention Arm | Procedure | - | jAnu-bastiH, जानु-बस्तिः | (Procedure Reference: BHAISHJYA RATNAWALI, Procedure details: JANU BASTI WILL BE PERFORMED WITH MURCHHIT TAILA FOR 15 DAYS IN JANUSANDHIGATA VATA PATIENT)
|
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients age more than 30 years and less than 70 years.
Patients with or without any deformity will be included.
Sign and Symptoms of Sandhigata Vata (Osteo arthritis of Knee) as Pain,Swelling,Stiffness,Tenderness,Crepitus,Pain during flexion and extension of Knee joints. |
|
| ExclusionCriteria |
| Details |
Patients age less than 30 years and more than 70 years.
Patients suffering from diseases like Gout( Vatarakta),Rheumatoid Arthritis(Amavata).
Pregnant women.
Over weight BMI more than 30.
Infective knee joint arthritis
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
The patients will be assessed mainly on the basis of improvement or relief in the cardinal symptoms of disesase.
To assess the effect of therapy subjectively all the sign and symptoms can be given on the basis of score of disease pattern depending upon the severity. |
60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction of C-reactive protein range |
60 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
|
Phase 2 |
|
Date of First Enrollment (India)
|
15/04/2026 |
| 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="0" 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
|
This study is parallel open level trial to evaluate the effect of Shatpushpadi Lepa and Janu Basti with Murchit til tail in the management of Janusandhigata vata with special reference to Osteoarthritis of Knee Joints. This study will perform on two group of 15 patients in each group .This study will be conducted in Government Ayurvedic College and Hospital Patna Bihar in department of Panchakarma .During 15 days of intervention four follow up will be done at every 15 days. |