| CTRI Number |
CTRI/2025/05/087808 [Registered on: 28/05/2025] Trial Registered Prospectively |
| Last Modified On: |
26/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Ayurvedic Enema Therapy for Hip Joint Bone Damage (AVN) A Clinical Study |
|
Scientific Title of Study
|
A Clinical Study to Evaluate the Therapeutic Efficacy of Saghrita Ksheer Basti in the Management of Asthi Majjagata Vata with Special Reference to Avascular Necrosis of Hip 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 OM PRAKASH CHAUDHARY |
| Designation |
PG Scholar |
| Affiliation |
Post Graduate Institute of Ayurved |
| Address |
PG Department of Panchakarma Post Graduate Institute of Ayurved
Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Campus
Kadvad Jodhpur
Jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
7451056877 |
| Fax |
|
| Email |
drniromchoudhary018@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gyan Prakash Sharma |
| Designation |
Associate Professor Head Of Department Panchakarma |
| Affiliation |
Post Graduate Institute of Ayurved |
| Address |
Room No 11 PG Department of Panchakarma Post Graduate
Institute of Ayurved Dr Sarvepalli Radhakrishnan Rajasthan Ayurved
University Campus Kadvad Jodhpur
Jodhpu
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9829798701 |
| Fax |
|
| Email |
atreyagyan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gyan Prakash Sharma |
| Designation |
Associate Professor Head Of Department Panchakarma |
| Affiliation |
Post Graduate Institute of Ayurved |
| Address |
Room No 11 PG Department of Panchakarma Post Graduate
Institute of Ayurved Dr Sarvepalli Radhakrishnan Rajasthan Ayurved
University Campus Kadvad Jodhpur
Jodhpu
RAJASTHAN
342037
India |
| Phone |
9829798701 |
| Fax |
|
| Email |
atreyagyan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute of Ayurved Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University
Jodhpur 342037 Rajasthan INDIA |
|
|
Primary Sponsor
|
| Name |
Post Graduate Institute of Ayurved DSRRAU Jodhpur |
| Address |
PG Department of Panchakarma Post Graduate Institute of Ayurved
DSRRAU Jodhpur 342037 Rajasthan INDIA |
| Type of Sponsor |
Government medical college |
|
|
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 OM PRAKASH CHAUDHARY |
Post Graduate Institute of Ayurved Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur |
PG Department of
Panchakarma Post
Graduate Institute of
Ayurved Dr Sarvepalli
Radhakrishnan
Rajasthan Ayurved
University Jodhpur
Nagaur Road Kadvad
Jodhpur
RAJASTHAN |
7451056877
drniromchoudhary018@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Post Graduate Institute of Ayurveda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M879||Osteonecrosis, unspecified. Ayurveda Condition: MAJJAGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म | (Procedure Reference: CHARAK SUTRASTHAN, Procedure details: Saghrita Ksheer Basti will be administered in Yapana Basti pattern for sixteen consecutive days
Pre procedure includes local massage with Tila Taila and steam fomentation
The enema will be given with medicated mixture prepared as per classical references
Patient will lie on left side and basti dravya will be administered rectally
Post procedure the patient will rest in supine position with legs slightly elevated and gentle foot massage will be done)
(1) Medicine Name: SAGHRITA KSHEER BASTI, Reference: KALPIT YOG, Route: Rectal, Dosage Form: Ksheerpaka, Dose: 450(ml), Frequency: od, Duration: 16 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients of either sex aged between 20 to 60 years
Presence of clinical signs and symptoms consistent with Asthi Majjagata Vata as described in classical Ayurvedic texts
Confirmed diagnosis of Avascular Necrosis AVN of the hip joint based on clinical evaluation and supported by radiological investigations such as Xray MRI or CT scan
Patients assessed to be eligible for Basti Karma Ayurvedic enema therapy
Patients who are willing to participate and provide informed written consent |
|
| ExclusionCriteria |
| Details |
Patients below the age of 20 years and above the age of 60 years
Patients having uncontrolled systemic diseases like hypertension diabetes mellitus active neoplastic diseases etc
Participants with conditions mimicking AVN such as inflammatory arthritis Potts spine bone tuberculosis traumatic injury or bone tumors
Participants with contraindications to the treatment being evaluated such as Saghrita Ksheer Basti
Pregnant and lactating women
Patients having stage four of avascular necrosis AVN |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the effect of Saghrita Ksheer Basti on subjective and objective parameters such as pain muscle strength joint mobility and functional capacity in patients of avascular necrosis of hip joint with clinical features of Asthi Majjagata Vata |
31 DAYS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The secondary outcome includes observing any
other effects of the drug & procedure, such as
changes in inflammation, patient satisfaction,
reduction in the need for conventional
medications, & overall quality of life
improvements |
31 DAYS |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
01/07/2025 |
| 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="0"
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 is an open label single arm exploratory clinical study to evaluate the therapeutic efficacy of Saghrita Ksheer Basti in the management of Asthi Majjagata Vata with special reference to Avascular Necrosis of the hip joint AVN A total of 30 patients between the age group of 20 to 60 years having clinical features of Asthi Majjagata Vata and confirmed diagnosis of AVN based on radiological investigations will be included The selected patients will be treated with Saghrita Ksheer Basti in Yapana Basti pattern for 16 days The effect of therapy will be assessed based on subjective parameters such as pain walking ability and muscle strength using Visual Analogue Scale VAS and Harris Hip Score as well as objective parameters including radiographic findings The study aims to evaluate the potential of Ayurvedic enema therapy in reducing symptoms and improving the quality of life in patients suffering from AVN of the hip joint |