| CTRI Number |
CTRI/2025/05/087354 [Registered on: 22/05/2025] Trial Registered Prospectively |
| Last Modified On: |
22/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare effect of nirgundi patra bandaging and nirgundi patra pottali fomentation in janusandhigat vata(knee osteoarthritis). |
|
Scientific Title of Study
|
A comparative clinical study of efficacy of nirgundi patra upnaha and nirgundi patra pinda sweda in janusandhigat vata with special reference to osteo arthritis 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 Ganesh Eknath Wagh |
| Designation |
Post Graduate Resident |
| Affiliation |
APMs Ayurved Mahavidyalaya, Near sion Railway station , sion Mumbai |
| Address |
Department of Panchakarma, second floor, APMs Ayurved Mahavidyalaya ,near sion Railway station ,sion mumbai
Near sion Railway station , sion Mumbai
Mumbai
MAHARASHTRA
400022
India |
| Phone |
8805119991 |
| Fax |
|
| Email |
gwagh90@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vishwajeet J Patade |
| Designation |
Professor |
| Affiliation |
APMs Ayurved Mahavidyalaya, Near sion Railway station , sion Mumbai |
| Address |
Department of Panchakarma, second floor, APMs Ayurved Mahavidyalaya ,near sion Railway station ,sion Mumbai
Near sion Railway station , sion Mumbai
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9869055701 |
| Fax |
|
| Email |
drvishup@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vishwajeet J Patade |
| Designation |
Professor |
| Affiliation |
APMs Ayurved Mahavidyalaya, Near sion Railway station , sion Mumbai |
| Address |
Department of Panchakarma, second floor, APMs Ayurved Mahavidyalaya ,near sion Railway station ,sion Mumbai
Near sion Railway station , sion Mumbai
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9869055701 |
| Fax |
|
| Email |
drvishup@gmail.com |
|
|
Source of Monetary or Material Support
|
| APMs Ayurved Mahavidyalaya,near sion railway station ,sion ,mumbai -400022 |
|
|
Primary Sponsor
|
| Name |
Seth RV Ayurvedic Hospital Sion |
| Address |
OPD no 1 Department of Panchakarma Near sion railway station Sion Mumbai 400022 Maharashtra |
| Type of Sponsor |
Other [Government Aided] |
|
|
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 Ganesh Eknath Wagh |
Seth RV Ayurvedic Hospital Sion |
OPD No 1 Department of panchakarma Near Sion railway Station sion mumbai 400022
Mumbai
MAHARASHTRA |
88051199991
gwagh90@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| APMs Ayurved Mahavidyalaya ,Sion IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M15-M19||Osteoarthritis. Ayurveda Condition: SANDHIGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | upanAhasvedaH (sAgniH, उपनाहस्वेदः (साग्निः) | (Procedure Reference: Sushrut samhita dalhan tikka adhyaya 32, Procedure details: Fresh leaves of Nirgundi are cut into small pieces and make its paste form.
50 ml Til taila taken in vessel having round bottom keep it on gas to get heat.
Fresh Nirgundi patra paste are added to the oil and stirred well to cook properly.
A bolus of this hot mixture is formed.
Take cotton cloth on table. Spread nirgundi patra over it properly.
Then place hot nirgundi patra bolus paste on it)
(1) Medicine Name: Nirgundi Patra , Reference: Bhavprakash Nighantu,Guduchyadi varga, Route: Topical, Dosage Form: Kalka/ Paste, Dose: 250(g), Frequency: od, Duration: 7 Days(2) Medicine Name: Tila taila, Reference: Bhavprakash Nighantu, Tail varga . sushrut sutrasthan 45, Route: Topical, Dosage Form: Taila, Dose: 100(ml), Frequency: od, Duration: 7 Days | | 2 | Comparator Arm | Procedure | - | piNDasvedaH, पिण्डस्वेदः | (Procedure Reference: Sushrut samhita dalhan tikka adhyaya 32, Procedure details: Take Vessel having round bottom.
Fresh Nirgundi leaves are cut into small pieces into vessel.
50ml Til Taila added to it.
Leaves fried with continuous stirring.
The 2 cotton cloth is spread on the working table.
Fried leaves collect over both cotton equally.
The free corners of cloth are approximated to cover the leaves. The free ends of the cloth are folded in its middle and then tied with a cotton thread and pottali made.
In a round bottomed vessel Tila Taila is taken and heated.
Patra Pottali Placed in it.
Patra Pottali must be continuously moved stirring in the oil, if the herbal pack is not moved there is chances of gets burnt.
Now the pottali is ready to use for procedure.)
(1) Medicine Name: Nirgundi Patra, Reference: Bhavprakash nighantu,Guduchyadi varga., Route: Topical, Dosage Form: Kalka/ Paste, Dose: 250(g), Frequency: od, Duration: 7 Days(2) Medicine Name: Tila taila, Reference: Bhavprakash Nighantu, Tailvarga. Sushrut sutrasthan 45, Route: Topical, Dosage Form: Taila, Dose: 100(ml), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
patient giving consent
patient having classical signs and symptoms of janusandhigata vata
janusandhishoola
janusandhishotha
Akunchana,prasarana vedana
Sandhiatopa
swedana yogya patient |
|
| ExclusionCriteria |
| Details |
Local skin infection,
ligament tear,hemorrhagic condition,
allergic to medicine (oil),
patient having history of knee joint surgery and knee transplant,
any disease other than osteoarthritis (e.g uncontrolled DM, Obesity, RA, Gout)
knee pain due to any trauma , open wound. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Janusandhi shool |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| sandhishoola, sandhishotha, akunchana prasaran vedana |
7 days |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 4 |
|
Date of First Enrollment (India)
|
02/06/2025 |
| 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="6"
Days="2" |
|
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
|
Knee osteoarthritis also called degenerative joint disease of the knee, usually occurs due to the gradual wearing down and loss of articular cartilage. It occurs most frequently in older women and men. Osteoarthritis is usually a degenerative condition that can ultimately result in disability. Osteoarthritis is a state of disease in which large amount of degenerative changes occur mostly in knee joint. Prevalence of Knee osteoarthritis in Mumbai is 3.62%.The clinical features of Sandhigata vata as described in Ayurveda are vatpurnadrutisparsh,shula, shotha, prasaran ankunchanyo pravruticchya vedana etc. Current treatment for degenerative disease is to control the symptoms, to control prolongation of the degenerative process and to lower the pain without Complication. We need to search for a safer, better and cheaper treatment, which improve functional ability in patients. Janusandhigata vata managed by various panchakarma procedures. In sandhigata vata chikitsa sutra upnaha sweda is mentioned. According to Acharya Dalhan Upnaha has 3 dividation- Pradeh, pinda, bandhan. So we have choosen Nirgundi patra pind and Nirgundi patra upnaha , As nirgundi has Vatshamak, vednashamak, shothagna, balya. Sandhigata vata is an asthi-sandhigata vyadhi, where there is kshya of Asthi Dhatu due to insufficient supply of Poshak Rasa. In Ayurveda text treatment of vatavyadhi given as Snehana , Swedana , Mridu Samshodhana, Basti and Vatahara Aushadha. |