| CTRI Number |
CTRI/2025/06/089059 [Registered on: 18/06/2025] Trial Registered Prospectively |
| Last Modified On: |
24/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical study to evaluate the efficacy of pooling of warm medicated oil in knee joint followed by an herbal enema and flaxseed poultice followed by herbal enema in the management of janu sandhigata vata wsr to osteoarthritis of knee joint |
|
Scientific Title of Study
|
An open label randomised comparative clinical study to
Evaluate the efficacy of janu basti followed by panchatikta
Ksheera basti and atasi upanaha followed by panchatikta
Ksheera basti in the management of janu sandhigata vata wsr
To osteoarthritis 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 Nalini J |
| Designation |
PG SCHOLAR |
| Affiliation |
Sri Kalabyraveshwaraswamy Ayurvedic Medical College Hospital and Research Centre |
| Address |
Room number 1
Department of panchakarma
Sri Kalabyraveshwaraswamy Ayurvedic Medical College Hospital and
Research Centre
10 Pipeline Road RPC Layout
Vijayanagar Bangalore karnataka india 560104
Bangalore
KARNATAKA
560104
India |
| Phone |
8072430567 |
| Fax |
|
| Email |
nani.jayakumar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Lolashri SJ |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
Sri Kalabyraveshwaraswamy Ayurvedic Medical College Hospital and Research Centre |
| Address |
Room number 1
Department of panchakarma
Sri Kalabyraveshwaraswamy Ayurvedic Medical College Hospital and
Research Centre
10 Pipeline Road RPC Layout
Vijayanagar Bangalore karnataka india 560104
Bangalore
KARNATAKA
560104
India |
| Phone |
9738671971 |
| Fax |
|
| Email |
sjlolashri@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR LOLASHRI SJ |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
Sri Kalabyraveshwaraswamy Ayurvedic Medical College Hospital and Research Centre |
| Address |
Room number 1
Department of panchakarma
Sri Kalabyraveshwaraswamy Ayurvedic Medical College Hospital and
Research Centre
10 Pipeline Road RPC Layout
Vijayanagar Bangalore karnataka india 560104
Bangalore
KARNATAKA
560104
India |
| Phone |
9738671971 |
| Fax |
|
| Email |
sjlolashri@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room number 1
Department of panchakarma
Sri Kalabyraveshwaraswamy Ayurvedic Medical College Hospital and
Research Centre
10 Pipeline Road RPC Layout
Vijayanagar Bangalore karnataka india 560104 |
|
|
Primary Sponsor
|
| Name |
Dr Nalini J |
| Address |
Room number 1
Department of panchakarma
Sri Kalabyraveshwaraswamy Ayurvedic Medical College Hospital and
Research Centre
10 Pipeline Road RPC Layout
Vijayanagar Bangalore karnataka india 560104 |
| 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 KIRAN M GOUD |
Sri Kalabyraveshwaraswamy Ayurvedic Medical College Hospital and Research Centre |
Room number 1
Department of panchakarma
Sri Kalabyraveshwaraswamy Ayurvedic Medical College Hospital and
Research Centre
10 Pipeline Road RPC Layout
Vijayanagar Bangalore karnataka india 560104
Bangalore
KARNATAKA |
9845109556
kiranmgoud@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Kalabyraveshwaraswamy Ayurvedic Medical College Hospital and Research Centre 10 Pipeline Road RPC Layout Vijayanagar Bangalore |
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: JANUSANDHIGATA VATA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | upanAhaH (niragniH), उपनाहः (निरग्निः) | (Procedure Reference: bhaishajya ratnavali, Procedure details: Panchaksheera basti of yoga basti pattern is given for 8 days follwed by athasi upanaha)
(1) Medicine Name: atasi upanaha, Reference: bhaishajya ratnavali, Route: Topical, Dosage Form: Churna/ Powder, Dose: 50(g), Frequency: od, Duration: 8 Days | | 2 | Comparator Arm | Procedure | - | bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म | (Procedure Reference: charaka samhitha, Procedure details: janu basti with murchitha tila taila is done for 30 minutes after the gap of 5 min panchaksheera basti of yoga basti pattern is given for 8 days)
(1) Medicine Name: panchatikta ksheera basti, Reference: charaka samhitha, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 576(ml), Frequency: od, Duration: 8 Days |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
subject presenting with lakshanas of janusandhigata vata
Clinical features of Osteoarthritis of knee joint subject presenting with radiological evidence of Osteoarthritis of knee joint
subject fit for snehana swedana and basti karma
|
|
| ExclusionCriteria |
| Details |
Patients presenting with history of systemic disorders, fractures and dislocation of knee joint. |
|
|
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 assess the reduction in pain and swelling in knee joint osteo arthritis |
Total duration of study is 8 days and follow up after 8 days of treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NA |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
30/06/2025 |
| 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="3"
Days="5" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Janu sandhigata vata is a disease affecting Asthi and Sandhis. Clinically Janusandhigata vata
presents vatapoorna drutisparsha shota, sandhigata anile, prasaranna akunchana savedana and
atopa as lakshana.
6 Acharya explained Snehana and Swedana are said to be the first line of
treatment in the management of Vatavyadhi7 meanwhile Bastikarma is said to be prime treatment
modality in Vatavyadhi and also it is explained as Ardha chikitsa.
8
Also, Charaka Samhita it is mentioned as Bahyabhyantraha snehairasthimajjagatam jayet.
9
In
asthimajjagata vikara both Bahya snehana and Abhyantara snehana are to be employed.
Janubasti is categorized under both Snehana and Swedana. Snehopanaha Agnikarma
Bandhanomardanani cha.10
In Sushruta Samhita, the chikitsa of Vatavyadhi is mentioned as
Snehana, Upanaha, Bandhana and Mardana. Upanaha is a form of swedana which is helpful in
reducing Sandhigata vata. Formulations like Atasi Upanaha11
and Salvana Upanaha are
mentioned in Classics. Also, Janubasti and Upanaha sweda are categorized under Bahirparimarjana Chikitsa. Meanwhile in Charaka Samhita it is explained that one should
administer Tiktaksheera basti in Asthipradosaja vikaras.Many research works have been
conducted on individual treatment modality of these. Hence, the present study has been
undertaken to analyse the combined action of Antar parimarjana and Bahirparimarjana Chikitsa
where in the effect of Janubasti followed by Panchatikta ksheera basti is compared with that of
Atasi upanaha followed by Panchatikta ksheera basti in the management of Janusandhigata vata
w.s.r to Osteoarthritis of knee joint |