| CTRI Number |
CTRI/2025/01/079603 [Registered on: 28/01/2025] Trial Registered Prospectively |
| Last Modified On: |
14/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative study of janubasti with Sahacharadi Taila and kubj prasarini taila in the management of janusandhigata vata w.s.r to osteoarthririts of knee joint |
|
Scientific Title of Study
|
An open label randomized clinical study to compare efficacy of Janu Basti with Sahacharadi Taila and Kubj Prasarini Taila in the management of Janusandhigata vata w.s.r to Osteoarthritis (O.A) 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)
Modification(s)
|
| Name |
Dr Pradeep Kumar Madhur |
| Designation |
Associate Professor |
| Affiliation |
Shubhdeep Ayurved Medical College and Hospital |
| Address |
OPD no. 07, Department of Panchakarma, Shubhdeep Ayurved Medical College and Hospital, Gram Datoda, Khandwa Road, near Chokhi Dhani, Indore, Madhya Pradesh, India, Pin code 452020
OPD no. 07, Department of Panchakarma, Shubhdeep Ayurved Medical College and Hospital, Gram Datoda, Khandwa Road, near Chokhi Dhani, Indore, Madhya Pradesh, India, Pin code 452020
Indore
MADHYA PRADESH
452020
India |
| Phone |
9425072818 |
| Fax |
|
| Email |
drpradeepmadhur@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arun Mishra |
| Designation |
Professor and HOD |
| Affiliation |
Mandsaur Institute of Ayurveda Education and Research, Mandsaur University, Mandsaur |
| Address |
OPD No.07, Department of Shalya Tantra, Mandsaur Institute of Ayurveda education and Research, Mandsaur University, Rewas Dewda Road, SH 31, Mandsaur, Madhya Pradesh, India, Pin code - 458001
Mandsaur
MADHYA PRADESH
458001
India |
| Phone |
8839664966 |
| Fax |
|
| Email |
arunmisra2007@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arun Mishra |
| Designation |
Professor and HOD |
| Affiliation |
Mandsaur Institute of Ayurveda Education and Research, Mandsaur University, Mandsaur |
| Address |
OPD No.07, Department of Shalya Tantra, Mandsaur Institute of Ayurveda education and Research, Mandsaur University, Rewas Dewda Road, SH 31, Mandsaur, Madhya Pradesh, India, Pin code - 458001
Mandsaur
MADHYA PRADESH
458001
India |
| Phone |
8839664966 |
| Fax |
|
| Email |
arunmisra2007@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shubhdeep Ayurved Medical College and Hospital, Gram Datoda, Khandwa road, near Chokhi Dhani, Indore, Madhya Pradesh, India, pin code 452020 |
|
|
Primary Sponsor
|
| Name |
Dr. Pradeep Kumar Madhur |
| Address |
OPD no. 07, Department of Panchakarma, Shubhdeep Ayurved Medical College and Hospital, Gram Datoda, Khandwa Road, near Chokhi Dhani, Indore, Madhya Pradesh, India, Pin code 452020 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Arun Mishra |
OPD No.07, Department of Shalya Tantra, Mandsaur Institute of Ayurveda education and Research, Mandsaur University, Rewas Dewda Road, SH 31, Mandsaur, Madhya Pradesh, India, Pin code - 458001 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pradeep Kumar Madhur |
Shubhdeep Ayurved Medical College and Hospital |
OPD no. 07, Department of Panchakarma,
Gram Datoda, Khandwa Road, near Chokhi Dhani, Indore, Madhya Pradesh, India, Pin code 452020
Indore
MADHYA PRADESH |
9425072818
drpradeepmadhur@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
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 | Procedure | - | jAnu-bastiH, जानु-बस्तिः | (Procedure Reference: Ashtang Hridaya chikitsasthana 21/67-69, Procedure details: Purvakarma - Sthanika Abhyang over janu pradesh with Sahacharadi Taila.
Pradhan Karma - Janubasti will be done as per classical method with Sahacharadi Taila for 30 minutes for 7 days.
Paschat Karma - Patient is cleaned after treatment and advised to take rest for one hour. Pathya and Apathya will be advised. )
(1) Medicine Name: Sahacharadi Taila , Reference: Ashtang Hridaya chikitsasthan 21/67-69, Route: Topical, Dosage Form: Taila, Dose: 50(ml), Frequency: od, Duration: 7 Days | | 2 | Intervention Arm | Procedure | - | jAnu-bastiH, जानु-बस्तिः | (Procedure Reference: Chakradatta -22/210-214, Procedure details: Purvakarma - sthanika Abhyang over janu pradesh with Kubja Prasarini Taila.
Pradhankarma - janubasti will be done as per classical method over janu pradesh with Kubja Prasarini Taila for 30 minutes for 7 days.
Paschat Karma - patient is cleaned after treatment and advised to take rest for one hour. Pathya and Apathya will be advised.)
(1) Medicine Name: Kubja Prasarini Taila , Reference: Chakradatta 22/210-214, Route: Topical, Dosage Form: Taila, Dose: 50(ml), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients having signs and symptoms of Janusandhigatavata.
a. Janusandhi shoola/joint pain
b. Janusandhi Shotha/joint swelling
c. Aakunchana prasaran Vedana/ painful joint movements.
d. Sandhigraha/ joint stiffness
e. Sparshasahyata/tenderness
f. Sandhisphutana/crepitation
2. X-Ray of Knee Joint showing degenerative changes of O.A. knee joint. |
|
| ExclusionCriteria |
| Details |
1. Patients who are below 35 and above 70 years of age.
2. Patients with known case of diabetes, Psoriatic arthritis, Systemic Lupus Erythematous
(SLE), Housemaid’s knee, Polymyalgia, Rheumatoid arthritis, Gout, Tuberculosis and
Patient with trauma will be excluded. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the efficacy of Janu Basti with Sahacharadi Taila and Kubj prasarini Taila in the
management of Janusandhigatavata w.s.r. to Osteoarthritis (O.A.) Knee joint |
baseline (visit 1) to end of treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To evaluate the efficacy of Sahacharadi Taila in Janusandhigatavata
2. To evaluate the efficacy of Kubj prasarini Taila in Janusandhigatavata |
baseline (visit 1) to end of treatment |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
08/02/2025 |
| 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="0"
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 a open label randomized clinical trial enrolling 100 subjects divided equally into 2 groups. Patients fulfilling the inclusion criteria will be enrolled for study. Group A will be given Sahacharadi Taila Janubasti and Group B will be given Kubj Prasrini Taila Janubasti. Both group will be given Janubasti for 7 days. The efficacy of the treatment will be evaluated on basis of various assessment criteria like Janusandhishoola (joint pain), Janusandhi shotha (Joint swelling), Aakunchana Prasarana vedana (Painful joint movements), Sandhigraha (Joint Stiffness), Sparshasahyata (tenderness), Sandhisphutana (Crepitation). The result will be assessed with regards to imrovement recorded in clinical findings. Assessment will be done by adopting proper statistical tools. The primary outcome of trial will be to evaluate efficacy of Janubasti with Sahacharadi Taila and Kubj prasarini taila and to compare both the drugs. |