| CTRI Number |
CTRI/2025/03/081603 [Registered on: 04/03/2025] Trial Registered Prospectively |
| Last Modified On: |
03/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Other (Specify) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Navaprasrutika Basti in Osteoarthritis Of Kneejoint |
|
Scientific Title of Study
|
A Comparative Clinical Study On Two Different Basti Schedules With Navaprasrutika Basti In Janu Sandhigata Vata Vis-a-Vis Osteoarthritis Of Kneejoint |
| 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 Bhagyashri Ankali |
| Designation |
PG Scholar |
| Affiliation |
Ayurveda Mahavidhyalaya And Hospital Heggeri Extension Hubli 580024 |
| Address |
Opd No 2 Department Of Panchakarma Ayurveda Mahavidhyalaya And Hospital Heggeri Extension Hubli 580024
Ayurveda Mahavidhyalaya College And Hospital Heggeri Extension Hubli 580024
Dharwad
KARNATAKA
580024
India |
| Phone |
8105477695 |
| Fax |
|
| Email |
bhagyashriankali123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Harish Kulkarni |
| Designation |
Professor Of Panchakarma Department |
| Affiliation |
Ayurveda Mahavidhyalaya And Hospital Hubli |
| Address |
Opd No 2 Department Of Panchakarma Ayurveda Mahavidhyalaya And Hospital Heggeri Extension Hubli 580024
Ayurveda Mahavidhyalaya College And Hospital Heggeri Extension Hubli 580024
Dharwad
KARNATAKA
580024
India |
| Phone |
9448501900 |
| Fax |
|
| Email |
harishpk2007@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhagyashri Ankali |
| Designation |
PG Scholar |
| Affiliation |
Ayurveda Mahavidhyala And Hospital Hubli |
| Address |
Opd No 2 Department Of Panchakarma Ayurveda Mahavidhyalaya College And Hospital Heggeri Extension Hubli 580024
Ayurveda Mahavidhyala College And Hospital Heggeri Extension Hubli 580024
Dharwad
KARNATAKA
580024
India |
| Phone |
8105477695 |
| Fax |
|
| Email |
bhagyashriankali123@gmail.com |
|
|
Source of Monetary or Material Support
|
| Opd No 2 Panchakarma Department
Ayurveda Mahavidhyalaya And Hospital Heggeri Extension Hubli 580024 |
|
|
Primary Sponsor
|
| Name |
Dr Bhagyashri Ankali |
| Address |
Opd No 2 Department Of Panchakarma Ayurveda Mahavidhyalaya And Hospital Heggeri Extension Hubli580024 |
| Type of Sponsor |
Other [In Ayurveda College] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Ayurveda Mahavidhyalaya And Hospital |
Ayurveda Mahavidhyalaya And Hospital Heggeri Extension Hubli 580024 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Bhagyashri Ankali |
Ayurveda Mahavidhyalaya And Hospitals Heggeri Extension Hubli 580024 |
Opd No2 Department Of Panchakarma
Ayurveda Mahavidhyalaya And Hospitals Heggeri Extension Hubli
Dharwad
KARNATAKA |
8105477695
bhagyashriankali123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ayurveda Mahavidhyalaya And Hospital Heggeri Extension Hubli |
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 | - | bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म | (Procedure Reference: Caraka Samhita Siddhistha 8th Chapter Verse 6 page No 713na, Procedure details: Caturbhadra Kalpa Basti Schedule Of 12 Days For Group A.
Niruha Basti Is Nava Prasrutika Basti
Anuvasana Basti With Ksheerabala Taila
)
| | 2 | Comparator Arm | Procedure | - | bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म | (Procedure Reference: Caraka Samhita Siddhisthana 8th Chapter VerseNo 6, Procedure details: Modified Kaala Basti Schedule Of 10 Days For Group B
Niruha Basti Is Nava Prasrutika Basti
Anuvasana Basti With Ksheerabala Taila)
|
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Subjects Fulfilling The Diagnostic Criteria
Subjects Who Are Fit For Basti Karma
Subjects Of Janu Sandhigata Vata With Chronicity Lessthan 10 Years. |
|
| ExclusionCriteria |
| Details |
Subjects with any congenital bony deformity.
Subjects of Amavata, Vatarakta, Janu Sandhigata Vata due to Abhigata.
Janu Sandhigata Vata secondary to endocrine dysfunction, septic arthritis, psoriatic
arthritis.
Subjects who are unfit for Basti Karma. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction In Pain And Stiffness |
4 to 5 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Increased Walking Time |
Group A - 37 Days
Group B - 31 Days |
|
|
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 3 |
|
Date of First Enrollment (India)
|
15/03/2025 |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Data are available indefinitely at (Link to be included bhagyashriankali123@gmail.com).
- For how long will this data be available start date provided 15-02-2025 and end date provided 15-02-2025?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Sandhigata Vata is the commonest form of articular disorder. It is a type of Vatavyadhi
which mainly occurs in Vriddhavasta due to Dhatukshaya, which limits everyday activities like
walking, dressing, etc. Thus, making patients disabled. It being the Vatavyadhi located in
Marmasthisandhi and its occurrence in old age makes it Kashtasadhya . Sandhigata Vata has
symptoms like Vatapoorna Dhruti Sparsha, Sandhishota, Prasarana Akunchanayoho
Pravrittischa Savedana, Hanthi Sandhi and Shopha. In Vataja Vyadhi Basti is regarded as Agrya.3 Basti is known as Ardhachikitsa. Nava
Prasrutika Basti is a type of Basti variety based on measurement of each ingredient, which will
be taken in Prasruta Pramana. It contains Brihatpancamula Kwatha, Taila, Madhu, Gritha. It is
indicated to promote strength and complexion.
Caturbhadra Kalpa Basti is a schedule mentioned by Acharya Kashyapa in which 4
Anuvasana Basti will be given in the beginning followed by 4 Niruha Basti in the middle and at
the end 4 Anuvasana Basti will be given, making it a 12 days schedule to complete. Kaala Basti
comprising of 10 Anuvasana Basti and 6 Niruha Basti, will require 16 days to complete when
given alternatively. But according to Acharya Charaka when Anuvasana Basti is given on the
same day of Niruha Basti , such a Basti schedule can be named as modified schedule which will
take 10 days to complete.
As no previous research work was done on the above told schedules, so an attempt
will be made two assess the efficacy of Caturbhadra Kalpa Basti of 12 days and modified Kaala
Basti of 10 days in Janu Sandhigata Vata. |