| CTRI Number |
CTRI/2024/10/075855 [Registered on: 24/10/2024] Trial Registered Prospectively |
| Last Modified On: |
22/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
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Type of Study
|
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
Analyzing the effect of ayurveda treatment according to Vatarakta and Asthimajjagatavata samprapti pathways in the patients of non traumatic avascular necrosis |
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Scientific Title of Study
|
Analysis of the Effect
of Ayurvedic Treatment Based on Vatarakta and Asthimajjagatavata Samprapti Pathways on the Clinico-radiological and Biochemical parameters in Patients of Non-traumatic Osteonecrosis of Femoral Head – A Black Box Clinical Trial
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| Trial Acronym |
nil |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Birupakshya Sahu |
| Designation |
MS SCHOLAR |
| Affiliation |
All India Institute of Ayurveda |
| Address |
5th floor Department of Shalya tantra All india Institute of Ayurveda gautampuri sarita vihar New Delhi
South
DELHI
110076
India |
| Phone |
8457977424 |
| Fax |
|
| Email |
birupakshya2050@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rashmi Bhise |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Ayurveda |
| Address |
5th floor Department of Shalya tantra All india Institute of Ayurveda gautampuri sarita vihar New Delhi
South
DELHI
110076
India |
| Phone |
9960183181 |
| Fax |
|
| Email |
shalyarashmi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rashmi Bhise |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Ayurveda |
| Address |
5th floor Department of Shalya tantra All india Institute of Ayurveda gautampuri sarita vihar New Delhi
South
DELHI
110076
India |
| Phone |
9960183181 |
| Fax |
|
| Email |
shalyarashmi@gmail.com |
|
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Source of Monetary or Material Support
|
| All India Institute of Ayurveda gautampuri sarita vihar new delhi 110076 |
|
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Primary Sponsor
|
| Name |
All India Institute of Ayurveda |
| Address |
Gautampuri Sarita vihar New Delhi
110076 |
| Type of Sponsor |
Government medical college |
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
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Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Birupakshya Sahu |
ALL INDIA INSTITUTE OF AYURVEDA |
opd no. 107 All India Institute Of Ayurveda Gautampuri Sarita Vihar New Delhi 110076
South
DELHI |
8457977424
birupakshya2050@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIA INSTITUTIONAL ETHICS COMMITTEE |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M879||Osteonecrosis, unspecified. Ayurveda Condition: VATARAKTAM, (2) ICD-10 Condition:M879||Osteonecrosis, unspecified. Ayurveda Condition: MAJJAGATAVATAH, |
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Intervention / Comparator Agent
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| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | jalaukAvacaraNam, जलौकावचरणमॠ| (Procedure Reference: sushrut samhita, Procedure details: along with jaloka ( 7 sitting once a week) kala basti will be given(niruh basti- yastimadhu kwatha siddha ksheerpaka and anuvasan basti- madhuyashti tail))
(1) Medicine Name: amrita kwath, Reference: sahasryoga, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 30(ml), Frequency: tds, Duration: 30 Days(2) Medicine Name: kaishora guggulu, Reference: bhisajyaratnawali, Route: Oral, Dosage Form: Guggulu, Dose: 250(mg), Frequency: tds, Duration: 30 Days | | 2 | Intervention Arm | Procedure | - | bastikarma/vastikarma, बसà¥à¤¤à¤¿à¤•à¤°à¥à¤®/वसà¥à¤¤à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: charak samhita, Procedure details: niruh basti- dashmool ksheer paka siddha
anuvasan basti- ksheerbala taila)
(1) Medicine Name: panchtikta gugguku ghrita, Reference: astanga hrdaya cikitsasthana, Route: Oral, Dosage Form: Ghrita, Dose: 20(g), Frequency: od, Duration: 30 Days(2) Medicine Name: dashmool ksheer paka, Reference: bhaisajyaratnawali, Route: Oral, Dosage Form: Ksheerpaka, Dose: 100(ml), Frequency: od, Duration: 30 Days |
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Inclusion Criteria
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| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)As per ICD-11 classification, Osteonecrosis of Femoral head belongs to Cluster code No. FB81.0&XA96S5
2)MRI Diagnosed cases of Osteonecrosis of Femoral head up to Steinberg Stage V will be included into the study
3)Patients suffering from Osteonecrosis of Femoral head in the age group of 20-60 years, irrespective of their gender, caste, religion, or socioeconomic status.
|
|
| ExclusionCriteria |
| Details |
1)Femoral neck fracture
2)Femoral neck stress fracture
3)Hip dislocation.
4)Surgically intervened cases
5)Hip Tendonitis and Bursitis
6)Uncontrolled diabetes mellitus
7)TB and Malignancy.
8)Cardiac disease
9)Pregnancy
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Method of Generating Random Sequence
|
Other |
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Method of Concealment
|
Other |
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Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| Documentation of the comparative analysis of the effect of Ayurvedic treatment based on vatarakta and asthimajjagata vata samprapti pathways on the clinico-radiological and biochemical parameters in patients of non-traumatic osteonecrosis of femoral head (ONFH) |
1st day
50th day
80th day |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
1)Quantification of the pre and post treatment extent of osteonecrosis of the femoral head based on the size, shape and volume of the involved area on CT and MRI scans.
2)Quantification of the pre and post treatment extent of osteonecrosis of the femoral head based on the modified Kerboul combined necrotic angle of the involved area on MRI scans.
3)Collection and analysis of the pre and post treatment clinical and biochemical parameters in non- traumatic ONFH patients in the two groups of the study.
|
1st day
50th day
80th day |
|
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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" |
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Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
05/11/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
RESEARCH QUESTION: Do Ayurvedic treatment regimens based on Vatarakta and Asthimajjagata vata samprapti pathways have any differential effect on the clinico-radiological and biochemical parameters in patients of non-traumatic osteo- necrosis of femoral head (ONFH)? HYPOTHESIS: The size, shape and volume of the involved area of femoral head will recede on CT and MRI evaluation and clinical and biochemical parameters will improve more in Vatarakta group as compared to Asthimajjagata vata group in patients of non-traumatic osteo-necrosis of femoral head (ONFH) following the Ayurvedic treatment based on these two samprapti pathways. NULL HYPOTHESIS:(H0) The size, shape and volume of the involved area of femoral head as measured on CT and MRI and clinical and biochemical parameters will remain unchanged irrespective of the Ayurvedic treatment based on Vatarakta and Asthimajjagata vata samprapti pathways in patients of non-traumatic osteo-necrosis of femoral head (ONFH). GAP IN THE KNOWLEDGE: To the best of our understanding, the clinico-radiological and biochemical evaluation of the effect of the Ayurvedic treatment based on Vatarakta and Asthimajjagata vata samprapti pathways in patients of non-traumatic osteo-necrosis of femoral head (ONFH) has not been studied in Ayurveda literature so far.
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