| CTRI Number |
CTRI/2025/07/091907 [Registered on: 28/07/2025] Trial Registered Prospectively |
| Last Modified On: |
25/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
to compare the effect of an ayurvedic medicine with ayurvedic enema in treating avascular necrosis |
|
Scientific Title of Study
|
A Comparative Study to Evaluate the Efficacy of Gandh Tailam with manjisthadi ksheer basti and Panchtikta Ghrita guggul with manjisthadi ksheer basti in the management of Asthimajjagat Vata with special reference to Avascular Necrosis of 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 Diksha Daheriya |
| Designation |
MD scholar |
| Affiliation |
pt khushilal sharma govt Ayurvedic college and Institute Bhopal MP |
| Address |
PG department of kayachikitsa pt khushilal sharma govt(Auto) Ayurveda college and Institute Bhopal MP
PG department of kayachikitsa pt khushilal sharma govt(Auto) Ayurveda college and Institute Bhopal MP
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
7828247649 |
| Fax |
|
| Email |
pragyapragya605@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shwetal Shivhare |
| Designation |
Reader |
| Affiliation |
pt khushilal sharma govt Ayurvedic college and Institute Bhopal MP |
| Address |
PG department of kayachikitsa pt khushilal sharma govt(Auto) Ayurveda college and Institute Bhopal MP
PG department of kayachikitsa pt khushilal sharma govt(Auto) Ayurveda college and Institute Bhopal MP
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
9907898097 |
| Fax |
|
| Email |
go111280@gamil.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Diksha Daheriya |
| Designation |
MD scholar |
| Affiliation |
pt khushilal sharma govt Ayurvedic college and Institute Bhopal MP |
| Address |
PG department of kayachikitsa pt khushilal sharma govt(Auto) Ayurveda college and Institute Bhopal MP
PG department of kayachikitsa pt khushilal sharma govt(Auto) Ayurveda college and Institute Bhopal MP
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
7828247649 |
| Fax |
|
| Email |
pragyapragya605@gmail.com |
|
|
Source of Monetary or Material Support
|
| pt khushilal sharma Govt(Auto) Ayurveda college and Institute Bhoal MP |
|
|
Primary Sponsor
|
| Name |
pt khushilal sharma Govt(Auto) Ayurveda college and Institute Bhoal MP |
| Address |
PG Department of Kayachikitsa pt Khushilal sharma Govt (Auto) Ayurveda college and Institute Bhopal MP |
| Type of Sponsor |
Government funding agency |
|
|
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 Diksha Daheriya |
pt khushilal sharma govt (auto) ayurveda college and institute Bhopal MP |
room no 221PG department of kayachikitsa pt khushilal sharma govt(Auto) Ayurveda college and Institute Bhopal MP
PG department of kayachikitsa pt khushilal sharma govt(Auto) Ayurveda college and Institute Bhopal MP
Bhopal
MADHYA PRADESH |
07828247649
pragyapragya605@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee pt khushilal sharma government Ayurveda college and Institute Bhopal MP |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M873||Other secondary osteonecrosis. Ayurveda Condition: ASTHIGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Gandha tailam, Reference: bhaishijiyaratna, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Koushna jal), Additional Information: - | | 2 | Intervention Arm | Procedure | - | bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म | (Procedure Reference: charka Samhita chikitsa sthan chapter no 28 vatavyadhi , Procedure details: basti given after meal )
(1) Medicine Name: manjisthadhati kwath, Reference: bhavprakash, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 360(ml), Frequency: od, Duration: 16 Days | | 3 | Comparator Arm | Procedure | - | bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म | (Procedure Reference: charka Samhita chikitsa sthan chapter no 28 vatavyadhi , Procedure details: Basti given after meal
Purvkarma -sarvang abhyang swedan will be done.
Pradhan karma-patient will lie in left lateral position bending the left knee then basti with kwath administered.)
(1) Medicine Name: manjisthadhati kwath,, Reference: bhavprakash, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 360(ml), Frequency: od, Duration: 16 Days | | 4 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Panchatikta Ghrita guggulu, Reference: bhaishijiyaratnvali in vatarogadhikar, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: koushna jal), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients between the age group of 2 1-60 year of either sex or religion.Diagnosed cases ofAvascular necrosis of femoral head with X-ray or CT Scan of hip joint or MRIof hip joint.
Diagnosed case of Avascular necrosis with grade I to grade 3.
Patients willing to participate in the trial.
5-Classical sign and symptoms of Asthimajjagata vata(AVN) in trial with written consent. |
|
| ExclusionCriteria |
| Details |
Patients between the age group of 2 1-60 year of either sex or religion
Diagnosed cases ofAvascular necrosis of femoral head with X-ray or CT Scan of hip joint or MRIof hip joint
Diagnosed case of Avascular necrosis with grade I to grade 3
Patients willing to participate in the trial
Classical sign and symptoms of Asthimajjagata vata(AVN) in trial with written consent |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| It is expected that at the end of study we would be able to demonstrate the efficacy of Gandha tailam with manjisthadi ksheer basti and panchatikta Ghrita guggulu with Manjisthadiksheer basti in the management of Asthimajjagatavata with special reference to avascular necrosis of femoral head |
12 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
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 2 |
|
Date of First Enrollment (India)
|
25/08/2025 |
| 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
|
It is expected that at the end of study we would be able to demonstrate the efficacy of Gandha tailam with manjisthadi ksheer basti and panchatikta Ghrita guggulu with Manjisthadiksheer basti in the management of Asthimajjagatavata with special reference to avascular necrosis of femoral head |