| CTRI Number |
CTRI/2024/11/076351 [Registered on: 07/11/2024] Trial Registered Prospectively |
| Last Modified On: |
06/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Management of Osteoarthritis with ayurveda |
|
Scientific Title of Study
|
A Randomised Comparative Clinical Study to Evaluate the Efficacy of Paribhadradi pralepa and Paribhadradi ointment in the management of Janu Sandhigata Vata ( Knee Osteoarthritis) |
| 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 Chander Shekhar Sharma |
| Designation |
Professor |
| Affiliation |
Dayanand Ayurvedic College, Jalandhar city,Punjab |
| Address |
Dayanand Ayurvedic College Opp. burlton park, Mahatma Hans Raj marg, Jalandhar city
Jalandhar
PUNJAB
144009
India |
| Phone |
9417785499 |
| Fax |
|
| Email |
shekhars76@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rakesh pawar |
| Designation |
Professor |
| Affiliation |
Desh Bhagat Ayurvedic College and Hospital |
| Address |
Desh Bhagat Ayurvedic College and Hospital, Amloh Road, Village Sounti Teh. Amloh District Fatehgarh Sahib,Punjab
Fatehgarh Sahib
PUNJAB
147203
India |
| Phone |
7505039976 |
| Fax |
|
| Email |
drpawar57@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chander Shekhar Sharma |
| Designation |
Professor |
| Affiliation |
Dayanand Ayurvedic College, Jalandhar city ,Punjab |
| Address |
Room No 1, Dayanand Ayurvedic College Opp. burlton park, Mahatma Hans Raj marg, Jalandhar city
Jalandhar
PUNJAB
144009
India |
| Phone |
9417785499 |
| Fax |
|
| Email |
shekhars76@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dayanand Ayurvedic College Opp. burlton park, Mahatma Hans Raj marg, Jalandhar city 144008 |
|
|
Primary Sponsor
|
| Name |
Not sponsored |
| Address |
NA |
| Type of Sponsor |
Other [NIL] |
|
|
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 Chander Shekhar Sharma |
Dayanand Ayurvedic college, Jalandhar,Punjab |
Department of kayachikitsa, Room No.1
Jalandhar
PUNJAB |
9417785499
shekhars76@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| University ethical 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 | Drug | Other than Classical | | (1) Medicine Name: Paribhdradi Ointment( Modified form of Paribhdradi pralepa), Reference: NA, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 00(NA), Frequency: hs, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 15 Days, Reference: NA, Route: , Dosage Form: Malahara/ Ointment/ Balm, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (3) Medicine Name: 15 Days, Reference: NA, Route: , Dosage Form: Malahara/ Ointment/ Balm, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: | | 2 | Intervention Arm | Procedure | - | upnah | (Procedure Reference: Kumara GUA, Wadimuna WMDRW, Pushpakumari WLARS, Clinical efficacy of Paribhadradi Pralepa on Sandhigata Vata (Osteoarthritis). J Ayu Int Med Sci. 2023;8(1):1-7, Procedure details: to be applied on knee joints overnight)
(1) Medicine Name: paribhdradi pralepa, Reference: Kumara GUA, Wadimuna WMDRW, Pushpakumari WLARS, Clinical efficacy of Paribhadradi Pralepa on Sandhigata Vata (Osteoarthritis). J Ayu Int Med Sci. 2023;8(1):1-7, Route: Topical, Dosage Form: Not Applicable, Dose: 00(NA), Frequency: hs, Duration: 15 Days |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients in the age group of 40 to 70 years of either sex.
2. Patients having signs and symptoms of Janusandhigata Vata of Shotha
(edema), Vatapurnadriti Sparsha (on palpation revealed as air filled bag) and pain
with Prasaran (extension) and Akunchan (flexion) movements.
3. Patients having chronicity of disease Janusandhigata Vata (KOA) for less
than 5 years.
4. Patients willing to sign consent form for the clinical trial.
5. Kellgren Lawrence (Radiological scale) of e†≥2
13 |
|
| ExclusionCriteria |
| Details |
1. Patients below 40 years and above 70 years of age.
2. Patients of Rheumatoid arthritis, Ankylosing and traumatic arthritis.
3. Patients suffering from paralysis, muscular dystrophy, polio or bony deformities.
4. Patients having systemic conditions such as Tuberculosis, Brucellosis,
Osteomyelitis,
Gouty Arthritis, Psoriatic Arthritis and Systemic Lupus Erythematosus
5. Patients having neoplasm of spine and other complicated diseases like CCF, DM,
Uncontrolled HTN, Unstable Angina, Recent MI etc.
6. Patients using anti-inflammatory medicines including Allopathic medicine and
AYUSH medicines. |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
The expected outcome of the study would ideally demonstrate the efficacy of both
Paribhadradi Pralepa and Paribhadradi ointment in improving pain, functionality, and
quality of life in patients with knee osteoarthritis, while also ensuring their safety and
tolerability profile.
|
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in hospital visits after completion of trial |
30 days |
|
|
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 |
|
Date of First Enrollment (India)
|
20/11/2024 |
| 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="3"
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, patients will be recruited from the Outpatient Department of Kaya Chikitsa at M.C. DAV Hospital in Jalandhar. Selection will be based on specific inclusion and exclusion criteria. Prior to enrollment, routine investigations will be conducted to ensure eligibility for participation in the study.This study aims to compare the efficacy of Paribhadradi Pralepa and Paribhadradi Ointment in managing symptoms of knee osteoarthritis, focusing on pain relief, functional improvement, and quality of life. Knee osteoarthritis (Janu Sandhigata Vata) is a prevalent condition that causes pain and disability. Traditional Ayurvedic treatments,( Paribhadradi Pralepa and Paribhadradi Ointment )comparative efficacy requires systematic evaluation..Paribhadradi Pralepa & Paribhadradi Ointment will be applied on Knee joints
only at night and keep it on until the following morning, approximately eight hours.The findings of proposed study will support the integration of Ayurvedic treatments in the management of osteoarthritis and warrant further investigation into long-term effects and mechanisms of action |