Comparison of Tikta Ksheer Basti ad Matra Basti after Virechana Karma in Avascular Necrosis of Femoral Head.

Phase 3

Not yet recruiting

• Conditions: Idiopathic aseptic necrosis of bone,

• Registration Number: CTRI/2020/09/028174
• Lead Sponsor: IPGT and RA

Brief Summary

**Purpose of the research**:Avascular necrosis (AVN) is additionally referred toas osteonecrosis, bone necrosis, bone infarction, aseptic necrosis and ischemicnecrosis. It is a condition in which the bone "dies" as a result ofloss of blood supply to an area of bone tissue. In extreme cases, it may resultin the collapse of a section of bone. Once the joint surface is involved, itmay result to progressive arthritis. Avascular necrosis (AVN) can affect knee,shoulder, wrist, ankle, hands and feet. Among them the femoral head is the mostcommon type of necrosis affecting the bones. In India, 16000 new cases of AVNare diagnosed every year. Management of AVN aims at the preservation ofstructure, function and relief from pain. Many surgical procedures such asdrilling and insertion of bone grafts etc. are carried out to treat thecondition but all these procedures are costly with the prognosis being poor. Signsand symptoms of Avascular necrosis are nearer to *AsthivÄha Srotoduṣṭi VikÄra*(disorders of musculoskeletal origin) and can be considered with *AsthimajjagatVata* (chronic stage). An effort has been made in the present study toevaluate the efficiency of *Ayurvedic* formulations in the conservativemanagement of AVN of the femoral head. The changing life style of human beingby means of dietetic and behavior pattern plays a major role in themanifestation of several disorders. The ages of 25 and 45, and is a chronicdisabling condition often causing pain and deformity. The present study aims toassess and compare the effect of Virechana Karma and Basti Karma in themanagement of AVN of Femoral Head. Patients will be randomly grouped into GroupA or Group B.  In **Group A**, Virechanakarma followed by *Ksheera Basti* for 16 days. In **Group B**, Virechan karmafollowed by Matra Basti karma for 16 days. The research takes place over 30days with 1 month follow up period in total for group A, and group B. It willbe necessary for patients to admit in the hospital   in group A & group B. **Duration:**Theresearch takes place over 30 days with 1 month follow up period in total forgroup A, and group B. It will be necessary for you to admit in the hospital for18 days in group A & group B. **Side Effects:**Asalready mentioned, this drug has no known unwanted effect. It is possible thatit may also cause some problems that we are not aware of. However, we willfollow you closely and keep track of any unwanted effects. We may use someother medicines to decrease the symptoms of the side effects or we may stop theusage of drug. You will always be consulted before moving to the next step. **Risks:**Byparticipating in this research, it is possible that you will be at greater riskthan you would otherwise be.  Forexample, there is a risk that your disease will not be relieved and that thenew medicine does not even work as the old one. If the medicine is not yielding any positive effect on AVN in fourweeks, we will offer you to choose other treatment options which may be modern,Ayurvedic or any other. **Benefits:**Ifyou participate in this research, your participation will help us to resolvethe research question.  There may not beany benefit for the society at this stage of the research, but futuregenerations are likely to be benefited. **Confidentiality:**Wewill not be sharing the identity of those persons participating in theresearch. The information that we collect from this research project will bekept confidential. It will not be shared with or given to anyone except me andthe DRC members.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2020-09-18
• Study Start: 2021-04-01

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Relief in Sign and Symptoms	At baseline and After 4 weeks

Secondary Outcome Measures

Name	Time	Method
Improve the quality of life of patient	At baseline and After 4 weeks

Trial Locations

Locations (1)

PG Ayurved hospital; 🇮🇳 Jamnagar, GUJARAT, India

PG Ayurved hospital

🇮🇳Jamnagar, GUJARAT, India

Pooja Soni

Principal investigator

7778971265

poojasoni1712@gmail.com