| CTRI Number |
CTRI/2025/03/082136 [Registered on: 11/03/2025] Trial Registered Prospectively |
| Last Modified On: |
20/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
"Comparison of Two Ayurvedic Treatments for Knee Osteoarthritis: Madhutailik Basti vs. Ardhamatrik Basti" |
|
Scientific Title of Study
|
Randomized controlled clinical trial to compare the efficasy of Madhutailik basti and Ardhamatrik basti in Janusandhigatvata. |
| 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 Jyoti Vishwanath Pate |
| Designation |
PG Scholar MD Panchakarma |
| Affiliation |
MES Ayurved Mahavidyalaya |
| Address |
Second floor, Panchakarma department, PG Section, MES Ayurved Mahavidyalaya, Ghanekhunt Lote, Khed, Ratnagiri Maharashtra
415722 India.
Ratnagiri
MAHARASHTRA
415722
India
Second floor, Panchakarma department, PG Section, MES Ayurved Mahavidyalaya, Ghanekhunt Lote, Khed, Ratnagiri Maharashtra
415722 India.
Ratnagiri
MAHARASHTRA
415722
India
Ratnagiri
MAHARASHTRA
415722
India |
| Phone |
9822369717 |
| Fax |
|
| Email |
jyotipate7777@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vd Vrushali Santosh Swami |
| Designation |
HOD & Professor MD Panchakarma |
| Affiliation |
MES Ayurved Mahavidyalaya |
| Address |
Second floor, Panchakarma department, PG Section, MES Ayurved Mahavidyalaya, Ghanekhunt Lote, Khed, Ratnagiri Maharashtra
415722 India.
Ratnagiri
MAHARASHTRA
415722
India
Second floor, Panchakarma department, PG Section, MES Ayurved Mahavidyalaya, Ghanekhunt Lote, Khed, Ratnagiri Maharashtra
415722 India.
Ratnagiri
MAHARASHTRA
415722
India
Ratnagiri
MAHARASHTRA
415722
India |
| Phone |
9422856123 |
| Fax |
|
| Email |
vrushaliswami2009@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrJyoti Vishwanath Pate |
| Designation |
PG Scholar MD Panchkarma |
| Affiliation |
MES Ayurved Mahavidyalaya |
| Address |
Second floor, Panchakarma department, PG Section, MES Ayurved Mahavidyalaya, Ghanekhunt Lote, Khed, Ratnagiri Maharashtra
415722 India.
Ratnagiri
MAHARASHTRA
415722
India
Second floor, Panchakarma department, PG Section, MES Ayurved Mahavidyalaya, Ghanekhunt Lote, Khed, Ratnagiri Maharashtra
415722 India.
Ratnagiri
MAHARASHTRA
415722
India
Ratnagiri
MAHARASHTRA
415722
India |
| Phone |
9822369717 |
| Fax |
|
| Email |
jyotipate7777@gmil.com |
|
|
Source of Monetary or Material Support
|
| MES Ayurved Mahavidyalaya & attached Parshuram Hospital & Research Center, Ghanekhunt Lote, Khed, Ratnagiri, Maharashtra, India-415722. |
|
|
Primary Sponsor
|
| Name |
Dr.Jyoti Vishwanath Pate |
| Address |
MES Ayurved Mahavidyalaya, Ghanekhunt Lote, Khed, Ratnagiri, Maharashtra, India-415722 |
| 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 Jyoti Vishwanath Pate |
MESAM Parashuram Hospital |
Panchakarma OPD no-4 Ghanekhunt-Lote PIN
415722 Tal-Khed Dist-Ratnagiri State
Maharashtra Country India Ratnagiri MAHARASHTRA
Mumbai
MAHARASHTRA |
9822369717
jyotipate7777@gmil.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MES Ayurved mahavidyalaya ethics committee |
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: SANDHIGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म | (Procedure Reference: chakradatta niruhadhikara, Procedure details: On the day of basti, sthanika snehana15(local external oleationwithtila taila & sthanika nadi swedana16at low back and abdomen will be done.
Pradhan Karma-
A.Position-Patient will be given left lateral position (Vama
Parshwa)16that is left leg will be asked to keep straight and
right leg folded.
B.Basti will be given by basti putak method.
C.Tila taila will be applied to anal opening
The patient will be asked to take deep inspiration. The
uniform pressure will be applied on Basti Putak, so as to allow Basti to enter into the rectum by keeping little quantity behind.
Paschat Karma-
A.The patient will be asked to lie down comfortably –supine
position. Sphika Tadana17will be done.
B.Basti pratyagama will be observed by prashna pariksha.
C.After basti pratyagama, patient will be advised to take bath
with sukhoshna jala and laghu bhojan will be advised.)
(1) Medicine Name: Ardhamatrik basti, Reference: chakradatta niruhadhikara, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 480(ml), Frequency: od, Duration: 8 Days | | 2 | Intervention Arm | Procedure | - | bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म | (Procedure Reference: sushrut chikitsastan 38/100,101, Procedure details: On the day of basti, sthanika snehana15(local external oleationwithtila taila & sthanika nadi swedana16at low back and abdomen will be done.
Pradhan Karma-
A.Position-Patient will be given left lateral position (Vama
Parshwa)16that is left leg will be asked to keep straight and
right leg folded.
B.Basti will be given by basti putak method.
C.Tila taila will be applied to anal opening
The patient will be asked to take deep inspiration. The
uniform pressure will be applied on Basti Putak, so as to allow Basti to enter into the rectum by keeping little quantity behind.
Paschat Karma-
A.The patient will be asked to lie down comfortably –supine
position. Sphika Tadana17will be done.
B.Basti pratyagama will be observed by prashna pariksha.
C.After basti pratyagama, patient will be advised to take bath
with sukhoshna jala and laghu bhojan will be advised.)
(1) Medicine Name: madhutailik basti, Reference: sushrut chikitsastan 38/100,101, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 690(ml), Frequency: od, Duration: 8 Days |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients having classical symptoms of janusandhigatvata.
2.Patients in the age group of 40-70 years.
3. Patients who are fit for basti.
4.Patients willing to give consent for research work. |
|
| ExclusionCriteria |
| Details |
1. Patients of age group below 40 years and above 70 years.
2. Patients having local rectal injury or any major illness.
3. Patients not willing to give consent for the research purpose. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Is Madhutailik basti more effective than Ardhamatrik basti in
janusandhigatvata ? |
follow up daily from day 1st to day 8th ,9th day, and 15th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Is Madhutailik Basti as effective as Ardhamatrik Basti in
Janusandhigata Vata? |
8 days study with follow up daily from 1st to 8th day and 9th ,15th day
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
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="6"
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
|
Title-RANDOMIZED CONTROLLED CLINICAL TRIAL TO COMPARE THE EFFICACY OF MADHUTAILIK BASTI AND ARDHAMATRIK BASTI IN JANUSANDHIGATVATA.
Null hypothesis (H0) : Madhutailik Basti is less effective as compared to Ardhamatrik basti In Janusandhigat Vata.
Alternative hypothesis (H1) : 1. Madhutailik Basti is more effective than Ardhamatrik basti in janusandhigatvata. 2. Madhutalik Basti is equally effective as Ardhamatrik basti in janusandhigatvata.
Study design– Randomized Controlled Clinical Trial
a) Inclusion criteria : 1.Patients having classical symptoms of janusandhigatvata. 2.Patients in the age group of 40-70 years. 3. Patients who are fit for basti. 4.Patients willing to give consent for research work.
b) Exclusion criteria : 1. Patients of age group below 40 years and above 70 years. 2. Patients having local rectal injury or any major illness. 3. Patients not willing to give consent for the research purpose.
Sample size- total 60 (30 for each group) Patients coming to OPD, IPD of our hospital with Janusandhihatvata (knee osteoarthritis ).
Simple randomized sampling (Lottery method)
Group A- ( TRIAL GROUP) Madhutailik basti
Group B ( CONTROL GROUP) Ardhamatrik basti
Total duration of Basti administration is 8 days. The mode of Basti administration will be by Per Rectal route.
Follow up- Follow up will be daily from 1st to 8th day then on 9th and 15 th day.
Result- Result will be drawn as per assessment criteria and statistical analysis |