| CTRI Number |
CTRI/2022/10/046235 [Registered on: 06/10/2022] Trial Registered Prospectively |
| Last Modified On: |
26/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) |
| Study Design |
Other |
|
Public Title of Study
|
A COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY of two formulations IN THE MANAGEMENT OF AMAVATA WITH SPECIAL REFERENCE TO RHEUMATOID ARTHRITIS |
|
Scientific Title of Study
|
A COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF SHOOLAPRSHAMANA CAPSULE AND HINGUTRIGUNA TAILA CAPSULE IN THE MANAGEMENT OF AMAVATA WITH SPECIAL REFERENCE TO RHEUMATOID ARTHRITIS |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Seeta MBiradar |
| Designation |
Professor |
| Affiliation |
BLDEAs AVS Ayurveda Mahavidylaya, |
| Address |
c/o BLDEAS AVS AYURVEDA MAHAVIDYALAYA VIJAYAPUR KARANATAKA
c/oBLDEAS AVS AYURVEDA MAHAVIDYALAYA VIJAYAPUR KARANATAKA
Bijapur
KARNATAKA
586109
India |
| Phone |
8951695201 |
| Fax |
|
| Email |
drseetabijapur@gmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Shivani Gavande |
| Designation |
Professor and Guide |
| Affiliation |
Parul Institute of Ayurveda |
| Address |
c/o Parul Institute of Ayurveda ,Parul Unversity PO Limda Ta Waghodia Dist Vadodara,Gujarat India
C/O Parul Institute of Ayurveda ,Parul Unversity Vadodara,Gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
9420205131 |
| Fax |
|
| Email |
shivani.gavande21706@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Seeta MBiradar |
| Designation |
Professor |
| Affiliation |
Parul Institute of Ayurveda |
| Address |
c/o BLDEAS AVS AYURVEDA MAHAVIDYALAYA VIJAYAPUR KARANATAKA
Ph.D scholar,Parul Institute of Ayurveda ,Parul University,Vadodara Gujarat
Bijapur
KARNATAKA
586109
India |
| Phone |
8951695201 |
| Fax |
|
| Email |
drseetabijapur@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Seeta M Biradar Professor
BLDEAS AVS Ayurveda Mahavidyalaa,Vijaapur
|
|
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Primary Sponsor
|
| Name |
Dr Seeta MBiradar |
| Address |
Parul Institute of Ayurveda Parul University Vadodara Gujarat |
| Type of Sponsor |
Other [Parul Institute of Ayurveda Parul University Vadodara Gujarat] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Seeta MBiradar |
BLDEAs AVS Ayurveda Hospital and Research centre,Vijayapur |
PARUL INSTITUTE OF AYURVEDA VADODARA GUJARAT AND BLDEAS AVS AYURVEDA MAHAVIDYALAYA VIJAYAPUR KARNATAKA
Bijapur
KARNATAKA |
8951695201
drseetabijapur@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| BLDEASAVSAYURVEDAMAHAVIDYALAYA HOSPITALANDRESEARCHCENTREVIJAYAPURVIDYANAGARBAGALKOTROADVIJAYAPUR586109 |
Approved |
| Institutional Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M049||Autoinflammatory syndrome, unspecified. Ayurveda Condition: AMAVATAH, (2) ICD-10 Condition:M049||Autoinflammatory syndrome, unspecified. Ayurveda Condition: AMAVATAH, (3) ICD-10 Condition: M368||Systemic disorders of connective tissue in other diseases classified elsewhere, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Shoolaprashamana choorna, Reference: CHARAKA SAMHITA SUTRASTHANA4TH CHAPTER, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 1 Months, anupAna/sahapAna: Yes(details: lukewarm water), Additional Information: -(2) Medicine Name: Hingutriguna taila , Reference: Astanga Hrdaya Gulma chikitsa, Route: Oral, Dosage Form: Taila, Dose: 10(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 1 Months, anupAna/sahapAna: Yes(details: lukewarm water), Additional Information: -(3) Medicine Name: Simhanad Guggulu , Reference: Bhaisajya Ratnavali ,Amavatadhikar 29cpt 190-195, Route: Oral, Dosage Form: Guggulu , Dose: 1(NA), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 1 Months, anupAna/sahapAna: Yes(details: -lukewarm water), Additional Information: - |
|
|
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Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
PATIENTS diagnosed as having Amavata on the basis of signs and symptoms that are typically diagnosed as classical symptoms and Rheumatoid Arthritis on basis of ACR CRITERIA FOR DIAGNOSING RHEUMATOID ARTHRITIS |
|
| ExclusionCriteria |
| Details |
patients suffering from complications of Aamavata
Juveline RA Septic arthritis Rheumatic Heart Disease
RA with involvement of other organs. |
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
Subjective parameters
Sandhi shoola
Sandhi shotha
Sparshasahatva
Stabdata
Angamarda
Aruchi
Alasya
Objective parameters
C-RP
ESR
Anti-CCP
RA factor
Assesment will be done on Pain Swelling Morning stiffness Tenderness Fever ESR score C-RP score DAS 28 score Disability Index Quality of Life Index SF36 by adapting standard methods of scoring. |
OBJECTIVE PARAMETERS
C-RP
ESR
RA factor
Anti-CCP
ASSESSMENT CRITERIA
Assessment will be made for clinical signs and symptoms & investigations Statistical analysis
package of version 20 will be done by using chi-square/Fisher’s test for subjective
parameters & students t test for objective parameters.
SAMPLE SIZE 120PATIENTS
60 Patients in each group and treatment for 1month with follow up of 15days
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Incidence of Amavata as per Age Sex Lifestyle will be made in Parul Institute of Ayurveda,Parul University Vadodara,Gujarat |
6months |
|
Target Sample Size
Modification(s)
|
Total Sample Size="165"
Sample Size from India="165"
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)
|
10/10/2022 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response (Others) - nil
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
Response - None of the above
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drseetabijapur@gmail.com].
- For how long will this data be available start date provided 10-10-2022 and end date provided 08-03-2023?
Response (Others) - nil
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
Brief Summary
Modification(s)
|
Amavata is a Pain predominant joint disorder which if not managed in time may prove crippling to the life of the patient, which has been causing immense suffering to the people throughout the world. Prevalance rate in India 0.75%.The ingredients of Shoolaprashamana capsule are anti-arthritic ,analgesic ,anti-inflammatory and muscle relaxants and specify aggravated vata dosha.The ingredients of Hingutrigunataila cap are Hingu,Saindhava,Eranda taila and Rasona.However using combination of drugs can be a novel approach in the treatment of Rheumatoid Arthritis.Moreover capsule is having easy palatability and is patient friendly .To get better idea about its efficacy and clinical spectrum a Comparative CLINICAL SYUDY is taken to see the efficacy of Shoolaprashamana capsule and Hingutriguna taila capsule. |