| CTRI Number |
CTRI/2025/02/080075 [Registered on: 07/02/2025] Trial Registered Prospectively |
| Last Modified On: |
28/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative Study on the Efficacy of Vishwadi-Dwadashanga Kwath Ghanavati and Rasnapanchaka Kwath Ghanavati with Panchatikta Ksheer Basti in Managing Avascular Necrosis of the Femoral Head (Asthimajjagata Vata) |
|
Scientific Title of Study
|
A
comparative study to evaluate the efficacy of Vishwadi-Dwadashanga Kwath ghanavati
and Rasnapanchaka Kwath Ghanavati along with Panchatikta Ksheer Basti in the
management of Asthimajjagata Vata w.s.r. 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 Ratnesh Kumar Shukla |
| Designation |
PG Scholar |
| Affiliation |
Pt. Khushilal Sharma Government (Autonomous) Ayurveda College and Institute Bhopal |
| Address |
Department of Kaya Chikitsa, Pt. Khushilal Sharma Government (Autonomous) Ayurveda College and Institute Bhopal
Science Hills, Nehru Nagar - Kolar Bypass Road,
Bhopal 462003 (M.P.) India
Department of Kaya Chikitsa
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
9340525166 |
| Fax |
|
| Email |
drratneshkumarshukla@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shraddha Sharma |
| Designation |
Assistant professor |
| Affiliation |
Pt. Khushilal Sharma govt (Autonomous) Ayurveda College and Institute Bhopal |
| Address |
Department of Kaya Chikitsa, Pt. Khushilal Sharma Government (Autonomous) Ayurveda College and Institute Bhopal
Science Hills, Nehru Nagar - Kolar Bypass Road,
Bhopal 462003 (M.P.) India
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
9907207327 |
| Fax |
|
| Email |
drshraddha.sharma@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ratnesh Kumar Shukla |
| Designation |
PG Scholar |
| Affiliation |
Pt. Khushilal Sharma Government (Autonomous) Ayurveda College and Institute Bhopal |
| Address |
Pt. Khushilal Sharma Government (Autonomous) Ayurveda College and Institute Bhopal
Science Hills, Nehru Nagar - Kolar Bypass Road,
Bhopal 462003 (M.P.) India
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
9827937247 |
| Fax |
|
| Email |
drratneshkumarshukla@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pt. Khushilal Sharma Government (Autonomous) Ayurveda College and Institute Bhopal Madhya Pradesh, india 462003, |
|
|
Primary Sponsor
|
| Name |
Pt Khushilal Sharma Government Autonomous Ayurveda College and Institute Bhopal |
| Address |
Department of kaya chikitsa, Pt. Khushilal Sharma Government (Autonomous) Ayurveda College and Institute Bhopal, Madhya Pradesh, India 462003 |
| 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 Ratnesh Kumar Shukla |
Ptkls Govt (Auto.) Ayurveda College and Institute Bhopal |
Room No. 221 PG
Department of
Kayachikitsa Pt.
Khushilal Sharma
Government
(Autonomous)
Ayurveda College and
Institute Bhopal MP
Bhopal
MADHYA PRADESH
Bhopal
MADHYA PRADESH |
9340525166
drratneshkumarshukla@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Pt Khushilal Sharma Govt Ayurveda College & Institute Bhopal MP |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M879||Osteonecrosis, unspecified. Ayurveda Condition: ASTHIGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म | (Procedure Reference: Charaka sutra, Procedure details: Panchatikta ksheer basti 16 days as kala basti pattern)
(1) Medicine Name: Rasnapanchaka kwath ghanavati, Reference: Chakradatta, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Duration: 30 Days | | 2 | Intervention Arm | Procedure | - | bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म | (Procedure Reference: Charaka Sutra 28, Procedure details: Panchatikta ksheer Basti 16 days as kala basti pattern)
(1) Medicine Name: Vishwadi dwadashanga ghanavati, Reference: Gada nigraha, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Duration: 30 Days |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
I. Patients between the age group of 20-60 year of either sex or religion.
II. Diagnosed cases of Avascular necrosis of femoral head with X-ray or CT of hip joint or MRI of hip joint.
III. Diagnosed case of Avascular necrosis with grade 1 to grade 3.
IV. Patients willing to participate in the trial.
|
|
| ExclusionCriteria |
| Details |
1. Patients below the age of 20 year and above the age of 60 year.
2. Diagnosed case of Avascular necrosis with grade 4.
3. Patients suffering from cardiac disease, pulmonary tuberculosis, bone tuberculosis, systemic lupus erythematous, Sickle cell anemia, HIV, severe lung disease, Endocrine disease(Cushing’s Syndrome.), pregnant & lactating women.
4. Patients of AVN with fractured, dislocation or severely deformed hip joint.
5. Patients unwilling to participate in the trial
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| It is expected that at the end of study we would be able to demonstrate the efficacy of Vishwadi-dwadashanga kwath ghanavati and Rasnapanchaka kwath ghanavati along with Panchatikta ksheer basti in the management of Asthimajjagata vata (AVN). |
12 Month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the improvement in clinical symptoms, functional outcomes, & quality of life in patients with Asthimajjagata Vata (AVN) after treatment with Vishwadi-dwadashanga kwath ghanavati, Rasnapanchaka kwath ghanavati, & Panchatikta ksheer basti. |
12 Month |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
20/02/2025 |
| 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 Vishwadi-dwadashanga
kwath ghanavati and Rasnapanchaka kwath ghanavati
along with Panchatikta ksheer basti in the management of Asthimajjagata
vata (AVN). |