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
|
|
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
|
|
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 AsthivÄha Srotoduá¹£á¹i VikÄra
(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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