CTRI/2023/02/049907 [Registered on: 20/02/2023] Trial Registered Prospectively
Last Modified On:
09/02/2023
Post Graduate Thesis
Yes
Type of Trial
Interventional
Type of Study
Drug Ayurveda Other (Specify) [panchakarma]
Study Design
Non-randomized, Multiple Arm Trial
Public Title of Study
management of avascular necrosis through ayurveda
Scientific Title of Study
Assess The Efficacy of Prakriti Related Customized Ayurveda Treatment Module In The Management of Asthimajjagata Vata (Avascular Necrosis of Femoral Head)- An Exploratory Study
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
NIL
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Sagar Vijay Therokar
Designation
PG Scholar
Affiliation
All India Institute of Ayurveda
Address
OPD No.6, Ground floor, Hospital Block, All India Institute of Ayurveda Gautampuri, Sarita Vihar, New Delhi 110076
New Delhi
DELHI
110076
India
New Delhi DELHI 110076 India
Phone
8408865119
Fax
Email
therokarsagar@gmail.com
Details of Contact Person Scientific Query
Name
Dr Prasanth Dharmarajan
Designation
Assistant Professor
Affiliation
All India Institute of Ayurveda
Address
Room No. 725, Department of Panchakarma Academic Block, All India Institute of Ayurveda Gautampuri, Sarita Vihar, New Delhi 110076
DELHI
110076
India
New Delhi DELHI 110076 India
Phone
9895174060
Fax
Email
drprasanthd@gmail.com
Details of Contact Person Public Query
Name
Dr Anandaraman P V
Designation
Professor And HOD
Affiliation
All India Institute of Ayurveda
Address
Room No. 704, Department of Panchakarma, Academic Block, All India Institute of Ayurveda Gautampuri, Sarita Vihar, New Delhi 110076
DELHI
110076
India
New Delhi DELHI 110076 India
Phone
9495130595
Fax
Email
dr.ananthramsharma@gmail.com
Source of Monetary or Material Support
All India Institute of Ayurveda Gautampuri sarita Vihar New Delhi 110076
Primary Sponsor
Name
All India Institute of Ayurveda
Address
All India Institute of Ayurveda Gautampuri, Sarita Vihar, New Delhi 110076
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
Dr Sagar Vijay Therokar
All India Institute of Ayurveda
OPD 6 Ground floor, Hospital block All India Institute of ayurveda Gautampuri, Sarita Vihar, New Delhi 110076
Delhi New Delhi DELHI
(Procedure Reference: ashtangahridya, Procedure details: hot fomentation will be given with dashmoola kwatha for 5-10 minutes for the period of 3 days) (1) Medicine Name: dashmoola kwatha, Reference: ashtanga hridya, Route: Topical, Dosage Form: Kwatha/Kashaya, Dose: 10(g), Frequency: od, Duration: 3 Days
10
Intervention Arm
Procedure
-
virecana-karma, विरेचन-करà¥à¤®
(Procedure Reference: ashtanga hridya, Procedure details: medicine will be given ) (1) Medicine Name: trivrit avleha and eranda taila, Reference: ashtanga hridya, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 70(ml), Frequency: od, Duration: 1 Days
11
Intervention Arm
Procedure
-
snehapana
(Procedure Reference: ashtangahridya, Procedure details: medicated ghee will be administed in incresing order starting from 30 ml for 3 -7 days) (1) Medicine Name: panchatikta gugglu ghrita, Reference: ashtangahridya, Route: Oral, Dosage Form: Ghrita, Dose: 30(ml), Frequency: od, Duration: 7 Days
12
Intervention Arm
Procedure
-
sarvanga abhyanga
(Procedure Reference: ashtanga hridya, Procedure details: massage will be done with tila taila for 30 minutes for 3 days ) (1) Medicine Name: tila taila, Reference: ashtanga hridya, Route: Topical, Dosage Form: Taila, Dose: 50(ml), Frequency: od, Duration: 3 Days
(Procedure Reference: sharangdhara samhita, Procedure details: 5gm shunthi churna will be given for the period of 3-7 days ) (1) Medicine Name: shunthi churna, Reference: ashtang hrudaya, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Duration: 7 Days
28
Comparator Arm
Procedure
-
aCasnehaH, अचà¥à¤›à¤¸à¥à¤¨à¥‡à¤¹à¤ƒ
(Procedure Reference: charak samhiita, Procedure details: snehapana will be done upto samyaka lakshana) (1) Medicine Name: panchatikta guggulu ghrita, Reference: ashtang hrudaya, Route: Oral, Dosage Form: Ghrita, Dose: 30(ml), Frequency: od, Duration: 7 Days
29
Comparator Arm
Procedure
-
sarvanga abhyanga
(Procedure Reference: charak samhita, Procedure details: abhyanga will be done for 3 days) (1) Medicine Name: tila taila, Reference: ashtnag hrudaya, Route: Topical, Dosage Form: Taila, Dose: 50(ml), Frequency: od, Duration: 3 Days
30
Comparator Arm
Procedure
-
sarvanga bashpa sweda
(Procedure Reference: charaka samhita, Procedure details: sarvannga bashpa sewdana will be done for 3 days) (1) Medicine Name: dashmool kwatha, Reference: ashtang hrudaya, Route: Topical, Dosage Form: Kwatha/Kashaya, Dose: 10(g), Frequency: od, Duration: 3 Days
31
Comparator Arm
Procedure
-
virecana-karma, विरेचन-करà¥à¤®
(Procedure Reference: ashatng hrudaya, Procedure details: virechana will be given with trivritta avaleha and triphala kwatha as anupana) (1) Medicine Name: trivritta avaleha, triphalla kwatha as anupana, Reference: ashtang hrudaya, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 70(g), Frequency: od, Duration: 1 Days
1.Patients who are fit to undergo Snehpana,
Virechana & Basti Karma
2.Chronicity: Upto 5 years.
3.Age between 16yrs to 65yrs.
4.Gender: Irrespectively both genders will be
considered for the study
5.Diagnosed cases of Avascular necrosis of
femoral head with MRI findings.
6.Socio-economic status: All
ExclusionCriteria
Details
Known cases of uncontrolled Diabetes,
Pulmonary tuberculosis other systemic
illnesses and pregnant women
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
Reduction in pain.
(Day-0)(Day-33)(Day-48)(Day-63)
Secondary Outcome
Outcome
TimePoints
Increase in Range of Motion
To determine change in Quality of life
(Day-0)(Day-33)(Day-48)(Day-63)
Target Sample Size
Total Sample Size="54" Sample Size from India="54" 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)
01/03/2023
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 Applicable
Recruitment Status of Trial (India)
Not Yet Recruiting
Publication Details
NIL
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
Avascular necrosis (AVN) is defined as cellular death of bone components due to interruption of the blood supply; the bone structures then collapse, resulting in pain, loss of joint function and long-term joint damage. Avascular necrosis of femoral head in the North Indian people is a disease of young individuals with male predominance. Steroid intake is most commonly observed in these patients followed by idiopathic, chronic alcohol consumption, and trauma Studies have attributed the disease process to the combined effect of genetic predisposition, metabolic factors and local factors affecting blood supply such as vascular damage, increased interosseous pressure and mechanical stress. This results in bone ischaemia.
Treatment modalities such as Deepana-Pachana, Snehpana, Virechana Karma, Patra pinda swedana & Basti karma Are Effective in the management of Asthimajjagata Vata.
Here in this study an attempt is made to find out the efficacy of customized treatment protocol as explain in Samhitas
OBJECTIVES OF THE RESEARCH PROJECT:
PRIMARY: 1) To determine the efficacy of Customized Ayurveda Treatment Module when given for a period of 63 days for reducing pain in Asthi-Majjagata Vata(Avascular necrosis of femoral Head) patients of 16-65yrs of age.
SECONDARY: 1) Subgroup Analysis would be Done Based on Prakriti. 2) To improve the range of motion in patients of Asthi-Majjagata Vata(Avascular necrosis of femoral head). 3) To Determine the change in Quality of Life in patients with Avascular necrosis of femoral head.
Study Type: Interventional Sub Type: Exploratory Timing: Prospective Masking: Open Label Grouping: Triple Arm Interventional Method: Parallel Study Site: Patients attending the Panchakarma OPD & IPD of AIIA fulfilling diagnostic criteria will be recruited