| CTRI Number |
CTRI/2025/07/091111 [Registered on: 17/07/2025] Trial Registered Prospectively |
| Last Modified On: |
14/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study to see the effect of retention time of enema and its outcome in knee joint pain |
|
Scientific Title of Study
|
An open labelled single arm interventional clinical study to assess the effect of prathyagamana kala of anuvasana basti and its outcome in janu sandhigata vata vis-a-vis 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 Rakshitha O |
| Designation |
Post Graduate Scholar |
| Affiliation |
JSS Ayurveda Medical College and Hospital |
| Address |
OPD2 Department of Panchakarma,JSS ayurveda hospital # 41/ E,Lalithadripura Road,
Mysuru, Karnataka 570028
Mysore KARNATAKA 570028 India |
| Phone |
07259544100 |
| Fax |
|
| Email |
rakshuom98@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Seetha Devi P |
| Designation |
Reader |
| Affiliation |
JSS Ayurveda Medical College and Hospital |
| Address |
OPD2 Department of Panchakarma,JSS ayurveda hospital # 41/ E,Lalithadripura Road,
Mysuru, Karnataka 570028
Mysore KARNATAKA 570028 India |
| Phone |
8431444499 |
| Fax |
|
| Email |
drsitadevi@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Seetha Devi P |
| Designation |
Reader |
| Affiliation |
JSS Ayurveda Medical College and Hospital |
| Address |
OPD2 Department of Panchakarma,JSS ayurveda hospital # 41/ E,Lalithadripura Road,
Mysuru, Karnataka 570028
Mysore KARNATAKA 570028 India |
| Phone |
8431444499 |
| Fax |
|
| Email |
drsitadevi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Panchakarma,JSS ayurveda hospital # 41/ E,Lalithadripura Road,
Mysuru, Karnataka 570028 |
|
|
Primary Sponsor
|
| Name |
Dr Rakshitha O |
| Address |
Department of Panchakarma,JSS ayurveda hospital # 41/ E,Lalithadripura Road,
Mysuru, Karnataka 570028 |
| 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 Rakshitha O |
JSS Ayurveda College and Hospital |
Room no 2,Department of Panchakarma OPD, # 41/ E,Lalithadripura Road,
Mysuru, Karnataka 570028 Mysore KARNATAKA |
07259544100
rakshuom98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committe, JSS Ayurveda Medical College, Mysuru |
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 | Intervention Arm | Procedure | - | anuvAsana-bastiH, अनुवासन-बस्तिः | (Procedure Reference: Caraka Samhita SiddhiStana 4, Procedure details: Purvakarma:Stanika Abyanga
Pradhana Karma: Anuvasana Basti 100ml with Balaaswagandhalakshadi Taila from Day 1 to 8.
Paschat Karma: When the administration is over, buttocks of the patient are patted with palms for three times and is advised to relax in supine position.then pillow is kept under the head of the patient and soles of the patient are gently rubbed.
In this relaxed position patient should wait for 100 Vak (time taken to count up to 100),
The patient may be allowed to take rest on the comfortable bed.)
|
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Subjects fulfilling the diagnostic criteria.
Subjects of either gender, aged between 30-70 years.
Subjects fit for Basti karma. |
|
| ExclusionCriteria |
| Details |
Traumatic, Infective, Neoplastic, Congenital diseases of joint and Rheumatoid
arthritis, Psoriatic arthritis.
Subjects with systemic disorders which interfere with the course of treatment.
Pregnant and lactating women. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Assess the effect of retention period of anuvasana Basti and its outcome in janusandhigata vata |
To Assess the effect of retention period of anuvasana Basti for 8 days and its outcome in janusandhigata vata |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Assess the improvement in signs & symptoms of janusandhigata vata |
9th day |
|
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
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)
|
25/07/2025 |
| 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="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
|
Basti chikitsa which is being called Ardha Chikitsa is considered as the best treatment for Vata Vyadhi. Anuvasana basti is a type of Snehabasti which is indicated in Vata vikaras. Janusandhigata vata is one among the vata vyadhi characterized by sandishula, shotha, vedana during prasarana and akunchana of sandhi, vatapurna druthi sparsha and occurs mostly in old age due to Dhatukshaya which limits a person’s routine activities. Acharya Charaka has mentioned the use of Snehana, Swedana, Basti and Mruduvirechana as the treatment of Vatavyadhi. Janusandhigata vata can be correlated to Osteoarthritis of Knee Joint. Osteoarthritis of Knee Joint is characterized by focal loss of Articular Cartilage, Subcondral osteosclerosis, osteophyte formation at the joint margin and remodelling of joint contour with enlargement. Principally targets the patella-femoral and medial tibio-femoral compartments but eventually spreads to affect the whole of the joint. The prevalence of osteoarthritis of Knee Joint rises progressively with age and it has been estimated that 45% of all people develop knee osteoarthritis at some point during life. Management includes Analgesics/topical NSAID, Oral NSAID, Joint replacement surgery, Strengthening exercises, etc. Now a days because of multiple influencing factors and bala of the patient, 1152ml/Dwadasha prasrutika niruha quantity is rarely practiced. Approximately 100ml will be given as anuvasana basti considering the routine practice of 8 to 9 prasruta quantity of niruha basti. Balaashwagandhalakshadi taila which is mentioned in Sahasrayoga is indicated in Vata vikaras. So, this study is intended to Assess the Prathyagamana kala of Balaashwagandha lakshadi taila anuvasana basti and its outcome in Janu sandhigata vata |