| CTRI Number |
CTRI/2025/03/082684 [Registered on: 19/03/2025] Trial Registered Prospectively |
| Last Modified On: |
18/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Efficacy of Nimbukadi pinda sweda & Nirgundi patra pinda sweda in management of Janusandhigat vata(Knee osteoarthritis) |
|
Scientific Title of Study
|
A Randomised comparative clinical trial to evaluate efficacy of Nimbukadi pinda sweda & Nirgundi Patra pinda sweda in the management of Janusandhigat vata. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vd Kannagi Rajesh Shende |
| Designation |
PG Scholar |
| Affiliation |
PDEAS college of Ayurved and research centre Nigdi Pune Maharashtra |
| Address |
PDEAS College of Ayurved and research center third floor Panchakarma department sector no 25 Nigdi Pune Maharashtra Pune 411044 India
Pune
MAHARASHTRA
411044
India |
| Phone |
7057374081 |
| Fax |
|
| Email |
Kannagirshende@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vd POURNIMA RIKIBE |
| Designation |
ASSOCIATE PROFFESOR |
| Affiliation |
PDEAS college of Ayurved and research centre Nigadi Pune Maharashtra |
| Address |
PDEAS College of Ayurved and research center third floor Panchakarma department sector no 25 Nigdi Pune Maharashtra Pune 411044 India
Pune
MAHARASHTRA
411044
India |
| Phone |
9762561699 |
| Fax |
|
| Email |
rikibepournima@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vd Kannagi Rajesh Shende |
| Designation |
PG scholar |
| Affiliation |
PDEAS college of Ayurved and research centre Nigdi Pune Maharashtra |
| Address |
PDEAS College of Ayurved and research center third floor Panchakarma department sector no 25 Nigdi Pune Maharashtra Pune 411044 India
Pune
MAHARASHTRA
411044
India |
| Phone |
7057374081 |
| Fax |
|
| Email |
Kannagirshende@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAS College Of Ayurved and Research Centre Sector no 25 Nigdi Pune 411044 |
|
|
Primary Sponsor
|
| Name |
PDEAS college of Ayurved and research centre Nigdi Pune |
| Address |
PDEAS COLLEGE OF AYURVED AND RESEARCH CENTRE SECTOR NO 25 NIGADI PUNE MAHARASHTRA PUNE 411044 INDIA |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Vd Kannagi Rajesh Shende |
Ayurved Rugnalaya And Snowbell Multispeciality Hospital Nigdi Pune |
Third Floor Panchakarma Department OPD No 216 Nigdi Pune Maharashtra 411044
Pune
MAHARASHTRA |
7057374081
Kannagirshende@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PDEAS COLLEGE INSTITUTIONAL ETHICAL COMMITTE |
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: JANUVISLESHAH (KEVALAVATA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | piNDasvedaH, पिण्डस्वेदः | (Procedure Reference: Tripathi B Charak Samhita sutrasthan chapter 14 verse 47, Procedure details: Preparation of Nimbukadi pottali with all ingredients fried in til oil, dipping it in warm oil apply over both knee joints for 10 minutes)
(1) Medicine Name: Nimbuk, Saindhav, Lashun, Turmeric powder, Reference: 10) Tikale S, Umate K, Tiwari M, Dhande N. An Ayurvedic Approach of Pinda Sweda and its Different Modalities. Int J Cur Res Rev| Vol. 2021 Apr;13(08):26, Route: Topical, Dosage Form: Not Applicable, Dose: 250(g), Frequency: od, Duration: 7 Days | | 2 | Comparator Arm | Procedure | - | piNDasvedaH, पिण्डस्वेदः | (Procedure Reference: Tripathi B Charak Samhita sutrasthan chapter 14 verse 47, Procedure details: Preparation of pottali of fried nirgundi patra in til oil, dipping of pottali in warm oil apply over both knee joint for 10 minutes)
(1) Medicine Name: Nirgundi Patra, Til oil , Reference: Atri V. Randomised control clinical study of nirgundyadi upanaha sweda in janusandhigatavata w.s.r. to knee osteoarthritis registered on CTRI/2022/05/047003, Route: Topical, Dosage Form: Not Applicable, Dose: 250(g), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients having cardinal symptoms of shoola(pain), shotha (swelling), vatpurna druti sparsha (crepitus), Pravruttisch savedana(pain during movements)
2)Swedan Arha- Vatavyadhi
3)Snehan Arha- Vatvikar
|
|
| ExclusionCriteria |
| Details |
1)Durbala & sukumara
2)Known case of Koshtukshirsha
3)Patient with congenital anomalies of knee.
4)History of - trauma, fracture, dislocation.
5)Patient having previous history of Arthoscopy or knee joint surgery.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the efficacy of Nimbukadi pinda sweda & Nirgundi Patra pinda sweda in management of Janusandhigata vata within 7 days
|
at day 3 and day 7
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe & compare the side effects if any |
To observe & compare the side effects if any in 7 days |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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)
|
01/04/2025 |
| 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
|
Vata Vyadhi affecting joints, specifically the major joints such as knees, hips, and shoulders. Among these, the knee joint (Janu Sandhi) is commonly affected in Sandhigata Vata.Sandhigata Vata manifests when vitiated Vata accumulates in the joints, leading to symptoms like pain (Shoola), swelling (Shotha), crepitus (Vatapurna Drutisparsha), and restricted movement (Pravruttisch savedana). This condition affects the bone (Asthi), joints (Sandhi), muscles (Mamsa), and ligaments (Snayu) in its pathology. swedan is the treatment for sandhigat vata. Pinda sweda is the best option for alleviating & conquering pain by using the herbs & fruits provided by nature. This research aims to enhance the recovery & give symptomatic relief to the patients. this study is aimed to compare the effectiveness of Nimbukadi pinda sweda & Nirgundi patra pinda sweda in management of janusandhigata vata. |