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CTRI Number  CTRI/2020/09/028174 [Registered on: 30/09/2020] Trial Registered Prospectively
Last Modified On: 18/09/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) [Panchakarma]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of Tikta Ksheer Basti ad Matra Basti after Virechana Karma in Avascular Necrosis of Femoral Head. 
Scientific Title of Study   Efficacy of Panchatikta Ksheera Basti and Panchatikta Ghrita Matra Basti after Virechana Karma in the management of Avascular Necrosis of Femoral Head w.s.r. to Asthimajjagata Vata. – An Open Labelled Randomized Comparative Clinical Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Pooja Soni 
Designation  MD Scholare 
Affiliation  IPGT and RA Jamnagar 
Address  Department of Panchakarma IPGT and RA Gujarat ayurved university, Jamnagar

Jamnagar
GUJARAT
361008
India 
Phone  7778971265  
Fax    
Email  poojasoni1712@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rahul S Gandhi 
Designation  Assistant Professor 
Affiliation  IPGT and RA Jamnagar 
Address  Department of Panchakarma IPGT and RA 4th floor Gujarat ayurved university, Jamnagar

Jamnagar
GUJARAT
361008
India 
Phone  9427451634  
Fax    
Email  drrahul@ayurveduniversity.com  
 
Details of Contact Person
Public Query
 
Name  Dr Rahul S Gandhi 
Designation  Assistant Professor 
Affiliation  IPGT and RA Jamnagar 
Address  Department of Panchakarma IPGT and RA 4th floor Gujarat ayurved university, Jamnagar

Jamnagar
GUJARAT
361008
India 
Phone  9427451634  
Fax    
Email  drrahul@ayurveduniversity.com  
 
Source of Monetary or Material Support  
Opposite reliance smart, Department of Panchakarma, IPGT and RA GAU, Jamnagar 
 
Primary Sponsor  
Name  IPGT and RA  
Address  IPGT and RA GAU Jamnagar Gujarat 
Type of Sponsor  Research institution and hospital 
 
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 
Pooja Soni  PG Ayurved hospital   Opd No 14 Department of Panchakarma
Jamnagar
GUJARAT 
7778971265

poojasoni1712@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M870||Idiopathic aseptic necrosis of bone,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Virechama Followed by Panchatikta Ghrita Matra Basti  In group B patient will undergo Deepan Pachana with Trikatu Churna 2gm TDS for 2-4 days followed by Snehpana with Goghrita for 3-7 days then Abhyanga with Bala Taila followed by Bashpa Swedana for 3 days then on 4th day Virechana with Eranda Taila and Godugdha will bw given. After Sansarjana Krama Panachatiktaghrita Matra Basti for 16 days will be administered.  
Intervention  Virechana Followed by Panchatikta Ksheer Basti  In group A patient will undergo Deepan Pachana with Trikatu Churna 2gm TDS for 2-4 days followed by Snehpana with Goghrita for 3-7 days then Abhyanga with Bala Taila followed by Bashpa Swedana for 3 days then on 4th day Virechana with Eranda Taila and Godugdha will bw given. After Sansarjana Krama Panachatikta Ksheer Basti for 16 days will be administered.  
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Patients of either sex.
2.Pre diagnosed patients of Avascular Necrosis of Femoral head either unilateral or bilateral at any stages.
3.Patients Yogya for Virechana Karma and Basti Karma.

 
 
ExclusionCriteria 
Details  1.Patients below the age of 25 and above the age of 65 years will be excluded in this study.
2.Patient having uncontrolled HTN, active neoplastic disease will be excluded.
3.Pregnancy, lactation.
4.Patients Ayogya for Virechana Karma and Basti Karma.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Relief in Sign and Symptoms  At baseline and After 4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Improve the quality of life of patient  At baseline and After 4 weeks 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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 
Date of First Enrollment (India)   04/01/2021 
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 Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not Published yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Purpose of the research: Avascular necrosis (AVN) is additionally referred to as osteonecrosis, bone necrosis, bone infarction, aseptic necrosis and ischemic necrosis. It is a condition in which the bone "dies" as a result of loss of blood supply to an area of bone tissue. In extreme cases, it may result in the collapse of a section of bone. Once the joint surface is involved, it may result to progressive arthritis. Avascular necrosis (AVN) can affect knee, shoulder, wrist, ankle, hands and feet. Among them the femoral head is the most common type of necrosis affecting the bones. In India, 16000 new cases of AVN are diagnosed every year. Management of AVN aims at the preservation of structure, function and relief from pain. Many surgical procedures such as drilling and insertion of bone grafts etc. are carried out to treat the condition but all these procedures are costly with the prognosis being poor. Signs and symptoms of Avascular necrosis are nearer to Asthivāha Srotoduṣṭi Vikāra (disorders of musculoskeletal origin) and can be considered with Asthimajjagat Vata (chronic stage). An effort has been made in the present study to evaluate the efficiency of Ayurvedic formulations in the conservative management of AVN of the femoral head. The changing life style of human being by means of dietetic and behavior pattern plays a major role in the manifestation of several disorders. The ages of 25 and 45, and is a chronic disabling condition often causing pain and deformity. The present study aims to assess and compare the effect of Virechana Karma and Basti Karma in the management of AVN of Femoral Head. Patients will be randomly grouped into Group A or Group B.  In Group A, Virechana karma followed by Ksheera Basti for 16 days. In Group B, Virechan karma followed by Matra Basti karma for 16 days. The research takes place over 30 days with 1 month follow up period in total for group A, and group B. It will be necessary for patients to admit in the hospital   in group A & group B. Duration: The research takes place over 30 days with 1 month follow up period in total for group A, and group B. It will be necessary for you to admit in the hospital for 18 days in group A & group B. Side Effects: As already mentioned, this drug has no known unwanted effect. It is possible that it may also cause some problems that we are not aware of. However, we will follow you closely and keep track of any unwanted effects. We may use some other medicines to decrease the symptoms of the side effects or we may stop the usage of drug. You will always be consulted before moving to the next step. Risks: By participating in this research, it is possible that you will be at greater risk than you would otherwise be.  For example, there is a risk that your disease will not be relieved and that the new medicine does not even work as the old one.  If the medicine is not yielding any positive effect on AVN in four weeks, we will offer you to choose other treatment options which may be modern, Ayurvedic or any other. Benefits: If you participate in this research, your participation will help us to resolve the research question.  There may not be any benefit for the society at this stage of the research, but future generations are likely to be benefited. Confidentiality: We will not be sharing the identity of those persons participating in the research. The information that we collect from this research project will be kept confidential. It will not be shared with or given to anyone except me and the DRC members.

 

 

 
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