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CTRI Number  CTRI/2025/10/096474 [Registered on: 27/10/2025] Trial Registered Prospectively
Last Modified On: 27/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of Ayurvedic Treatment with Gandh Tail Capsules and Dashmool Majja Basti in Avascular Necrosis of the Femoral Head. 
Scientific Title of Study   A comparative study to evaluate the efficacy of Gandh tail with Dashmool majja basti in the management of Asthimajjagata vat 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 Shwetal Shivhare 
Designation  PhD Scholar 
Affiliation  Parol Institute of Ayurveda Parol Univercity Vadodara Gujarat 
Address  Room number 401 Parul department of Kayachikitsa Institute of Ayurveda Parul University post office limda tal waghodia vadodara Gujarat Pin code 391760 Vadodara GUJARAT 391760 India
Room number 401 Parul department of Kayachikitsa Institute of Ayurveda Parul University post office limda tal waghodia vadodara Gujarat Pin code 391760 Vadodara
Vadodara
GUJARAT
391760
India 
Phone  9479904667  
Fax    
Email  Shwetalshivhare@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shivani Gavande  
Designation  Professor PhD  
Affiliation  Parul Institute of Ayurveda Parul University post office Limda Tal waghodia Vadodara Gujarat. 
Address  Room number 401 department of Kayachikitsa Parul Institute of Ayurveda Parul University post office limda tal waghodia vadodara Gujarat.
Room number 401 department of Kayachikitsa Parul Institute of Ayurveda Parul University post office limda tal waghodia vadodara Gujarat.
Vadodara
GUJARAT
391760
India 
Phone  9420205131  
Fax    
Email  drshivanigavande@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Shivani Gavande  
Designation  Professor PhD  
Affiliation  Parul Institute of Ayurveda Parul University post office Limda Tal waghodia Vadodara Gujarat. 
Address  Room number 401 department of Kayachikitsa Parul Institute of Ayurveda Parul University post office limda tal waghodia vadodara Gujarat.
Room number 401 department of Kayachikitsa Parul Institute of Ayurveda Parul University post office limda tal waghodia vadodara Gujarat.
Vadodara
GUJARAT
391760
India 
Phone  9420205131  
Fax    
Email  drshivanigavande@gmail.com  
 
Source of Monetary or Material Support  
Room number 401 department of Kayachikitsa Parul Institute of Ayurveda Parul University post office limda tal waghodia vadodara Gujarat. PIN code 391760 
 
Primary Sponsor  
Name  Dr Shwetal Shivhare 
Address  Room number 401 department of Kayachikitsa parul Institute of Ayurveda Parul University post office limda tal waghodia vadodara Gujarat Pin code 391760  
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shwetal Shivhare  Parol Institute of Ayurved Parol University Vadodara Gujarat  Room number 401 Parul department of Kayachikitsa Institute of Ayurveda Parul University post office limda tal waghodia vadodara Gujarat Pin code 391760 Vadodara
Vadodara
GUJARAT 		 9479904667

Shwetalshivhare@gamil.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
PARUL INSTITUTE OF AYURVED PAROL UNIVERSITY  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M879||Osteonecrosis, unspecified. Ayurveda Condition: MAJJAGATAVATAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म (Procedure Reference: Charak samhita chikitsa sthan 28/124-127, Procedure details: Dahmoolmajja basti 100ml after meal with Dashmool Niruha basti 350 ml before meal.)
(1) Medicine Name: Gandh tail, Reference: Astang hridrayam samhita uttar tantra 27/36, Route: Oral, Dosage Form: Taila, Dose: 20(ml), Frequency: bd, Duration: 90 Days
2Comparator Arm (Non Ayurveda)-Ibandronic Acid with calcium and vitamin DIbandronic Acid with calcium and vitamin D Ibandronic Acid 150mg once in a month for 3 months with water oral calcium 500mg bd per day for 60days with water Vitamin D 60000IU per week for 8weeks with water
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Patients willing to participate in the trial
Patients between the age group of 20-50 year of either sex or religion
Diagnosed case of Avascular necrosis with grade I to grade III
Diagnosed case of Avascular necrosis of femoral head with X-ray hip joint or CT scan or MRI of hip joint will be included in this study 
 
ExclusionCriteria 
Details  Patients unwilling to participate in the trial
Patients age are not less than 20 years or above 50 years
Diagnosed case of Avascular necrosis with grade IV
Patients suffering from cardiac disease and Severe lung disease
Endocrine disease like Cushing syndrome and sle sickle cell anemia
Patients with HIV Positive and having tuberculosis
Pregnant and lactating mothers should be excluded
Patients without written consent form 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
After the completion of therapy we will able to conclude the role of Gandh tail and majja basti describe in our classic on bone and joint disorder like AVN  Total duration 18 months and 3 month for control group 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="46"
Sample Size from India="46" 
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)   10/11/2025 
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  

The present clinical study aims to evaluate the efficacy of Gandha Taila in combination with Dashmooladi Majja Basti in the management of Asthimajjagata Vata with special reference to Avascular Necrosis (AVN) of the Femoral Head. The trial seeks to assess improvements in pain, joint mobility, and functional outcomes, and to explore the potential of this Ayurvedic management protocol as a safe and effective alternative or adjunct therapy for AVN patients.

 
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