| CTRI Number |
CTRI/2025/08/093451 [Registered on: 22/08/2025] Trial Registered Prospectively |
| Last Modified On: |
20/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare effect of Bruhatyadi Yapana Basti (enema) And Patoladi Niruha Basti for Avascular (enema)Necrosis of the Femoral head |
|
Scientific Title of Study
|
An Open Label Comparative Randomized Clinical Trial to Evaluate the efficacy of Bruhatyadi Yapana Basti and Patoladi Niruha Basti In the Management of Asthimajjagata Vata W.S.R Avascular Necrosis (AVN) of the Femoral Head |
| 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 Sunita |
| Designation |
PG Scholar |
| Affiliation |
Institute For Ayurved Studies And Research |
| Address |
OPD NO 29 Department of Panchkarma Institute For Ayurved Studies and Research Umri Road Sector 8 Kurukshetra
ROOM NO 68 Department of Panchkarma Institute for Ayurved Studies and Research Umri Road Sector 8
Kurukshetra
HARYANA
136118
India |
| Phone |
9306317131 |
| Fax |
|
| Email |
priyasunita123021@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Raja Singla |
| Designation |
Professor Department of Panchkarma |
| Affiliation |
Institute For Ayurved Studies And Research |
| Address |
ROOM NO 68 Department of Panchkarma Institute for Ayurved Studies and Research Umri Road Sector 8
OPD NO 29 Department of Panchkarma Institute for Ayurved Studies and Research Umri Road Sector 8
Kurukshetra
HARYANA
136118
India |
| Phone |
9996867471 |
| Fax |
|
| Email |
singla.raja37@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sunita |
| Designation |
PG Scholar |
| Affiliation |
Institute For Ayurved Studies And Research |
| Address |
OPD NO 29 Department of Panchkarma Institute for Ayurved Studies and Research Umri Road Sector 8
Kurukshetra
HARYANA
136118
India |
| Phone |
9306317131 |
| Fax |
|
| Email |
priyasunita123021@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute for Ayurved Studies And Research Shri Krishna AYUSH University umri road sector 8 Kurukshetra 136118 Haryana |
|
|
Primary Sponsor
|
| Name |
Institute For Ayurved Studies And Research |
| Address |
Umri Road Sector 8 Kurukshetra |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Sunita |
Institute For Ayurved Studies And Research |
OPD NO 29 Department of Panchkarma Institute for Ayurved Studies and Research Sector 8 Umri Road
Kurukshetra
HARYANA |
9306317131
priyasunita123021@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee SKAU Kurukshetra |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M878||Other osteonecrosis. Ayurveda Condition: ASTHIGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म | (Procedure Reference: Charaka Samhita Siddhi Sthana Chapter 12, Procedure details: Bruhatyadi Yapan Basti (Kala Basti) For 16 Days, Including Anuvasana Basti For 10 Days, Niruha Basti For 6 Days On Interval Basis As Mentioned In Samhita))
(1) Medicine Name: Bruhatyadi Yapan Basti, Reference: Charaka Samhita Siddhi Sthana Chapter 12, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 960(ml), Frequency: od, Duration: 6 Days | | 2 | Intervention Arm | Procedure | - | bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म | (Procedure Reference: Charaka Chikitsa Chapter 3, Procedure details: Patoladi Niruha Basti (Kala Basti) For 16 Days, Including Anuvasana Basti For 10 Days, Niruha Basti For 6 Days On Interval Basis As Mentioned In Samhita)
(1) Medicine Name: Patoladi Niruha Basti, Reference: Charaka Chikitsa Chapter 3, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 960(ml), Frequency: od, Duration: 6 Days |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient Having Classical Signs And Symptoms Of Asthimajjagata Vata
Patient Having Sign And Symptoms Of Avascular Necrosis Of Femoral Head Either Unilateral Or Bilateral Of Any Stages
Patients Yogya For Basti Karma |
|
| ExclusionCriteria |
| Details |
Patient Who Is Contraindicated For Basti
Patient With Chronic Systemic Illness Cardiac Disease Cirrhosis Of Liver Diabetes Hypertension Chronic Renal Disease Carcinoma
Pregnant And Lactating Women
Patient With Ano Rectal Disease
Patient Of AVN With Fractured Dislocation Severly Deformed Hip Joint
Patient Unwilling To Participate In The Trial
Patient Aged Below 25 Years And Above 60 Years |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in AsthiShoola Pain in Bones As Per Ayurvedic Criteria |
1st- 0 day
2nd- 16th day
3rd- 32nd day
4th- 48th day
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement In Mamsakshaya Muscles Hypotonia Aswapan Santat Ruka Sleeplessness Due To Continuous Pain Balakshaya Muscle Power Grading As Per Ayurvedic Criteria |
Follow Up on 16th 32nd 48th Day |
|
|
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)
|
15/11/2025 |
| 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 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
|
This study is a Randomized Open Label Clinical trial to evaluate the efficacy of Bruhatyadi Yapana Basti and Patoladi Niruha Basti in managing Asthimajjagata Vata with special reference to Avascular Necrosis of the Femoral head AVN is a progressive degenerative disorder caused by impaired blood supply parallel symptoms of Asthimajjagata Vata described in Ayurveda contemporary treatments like surgery have limitations whereas basti therapy offers a safe cost effective alternative Forty Patient will be randomly allocated into two groups receiving 16 days of Kala basti regimen The trial aims to compare symptomatic relief functional improvement and potential disease modifying outcomes |