| CTRI Number |
CTRI/2022/07/044321 [Registered on: 26/07/2022] Trial Registered Prospectively |
| Last Modified On: |
21/07/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A CLINICAL TRIAL TO STUDY THE EFFECT OF A MULTIPAL DRUG FORMULATION, SHALLAKIADI YOGA IN AMAVATA (RHEUMATOID ARTHRITIS) |
|
Scientific Title of Study
|
AN OPEN LABEL, SINGLE ARM, CLINICAL STUDY TO EVALUATE THE EFFECT OF SHALLAKIADI YOGA IN AMAVATA
(RHEUMATOID ARTHRITIS)
|
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR MEET SHARMA |
| Designation |
Postgraduate Scholar |
| Affiliation |
SDM COLLEGE OF AYURVEDA AND HOSPITAL |
| Address |
OPD 4 (Kayachikitsa OPD) SDM COLLEGE OF AYURVEDA AND HOSPITAL, BM Road, Thaniruhalla, Hassan
Hassan
KARNATAKA
573201
India |
| Phone |
9982563158 |
| Fax |
|
| Email |
dr.meetsharma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR GIRISH KJ |
| Designation |
PROFESSOR DEPT OF KAYACHIKITSA |
| Affiliation |
SDM COLLEGE OF AYURVEDA AND HOSPITAL |
| Address |
OPD 4 (Kayachikitsa OPD) SDM COLLEGE OF AYURVEDA AND HOSPITAL
Hassan
KARNATAKA
573201
India |
| Phone |
9448646855 |
| Fax |
|
| Email |
girideepa@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
DR GIRISH KJ |
| Designation |
PROFESSOR DEPT OF KAYACHIKITSA |
| Affiliation |
SDM COLLEGE OF AYURVEDA AND HOSPITAL |
| Address |
OPD 4 (Kayachikitsa OPD) SDM COLLEGE OF AYURVEDA AND HOSPITAL, BM ROAD, THANIRUHALLA, HASSAN
Hassan
KARNATAKA
573201
India |
| Phone |
9448646855 |
| Fax |
|
| Email |
girideepa@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| SDM COLLEGE OF AYURVEDA AND HOSPITAL ,HASSAN |
|
|
Primary Sponsor
|
| Name |
SDM COLLEGE OF AYURVEDA AND HOSPITAL |
| Address |
BM ROAD THANIRUHALLA HASSAN 573201 |
| Type of Sponsor |
Private medical college |
|
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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 GIRISH KJ |
SDM COLLEGE OF AYURVEDA AND HOSPITAL HASSAN |
OPD 4 (Kayachiktsa OPD), SDM COLLEGE OF AYURVEDA AND HOSPITAL HASSANBM ROAD THANIRUHALLA HASSAN
Hassan
KARNATAKA |
9448646855
girideepa@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| 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:M058||Other rheumatoid arthritis with rheumatoid factor. Ayurveda Condition: AMAVATA, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: SHALLAKIYAADI YOGA, Reference: ANUBHUTA YOGA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 2 Weeks, anupAna/sahapAna: Yes(details: WARM WATER), Additional Information: |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Amavata with features of Rheumatoid Arthritis as specified in 2010 ACR-EULAR classification criteria for Rheumatoid Arthritis with less than 5 years of chronicity (Parameters in ACR-EULAR criteria: Duration of symptoms, joint distribution, serology, acute phase reactants)
2. Subjects aged between 18 -75 years
3. Subjects of either gender
4. Subjects willing to participate in the study and ready to sign informed consent form
|
|
| ExclusionCriteria |
| Details |
1. Subjects with known case of uncontrolled hypertension, diabetes mellitus, renal, hepatic and cardiac function
2. Subjects with known case of Systemic arthritis (gout, tubercular arthritis, systemic lupus erythematosus, psoriatic arthritis)
3. Pregnant and lactating women
4. Subjects used/using Steroids more than 6 months
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| – Lakshanas of Amavata- angamarda, aruchi, trishna, alasya, gaurava, jwara, apaka, shotha, shoola, stabdhata of sandhi. |
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| – ACR EULAR score, DAS – 28 score[18],RAPID 3 score, grip strength, foot pressure. |
15 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
29/07/2022 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
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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
|
Amavata is a disease caused due to accumulated
ama and vitiated vata dosha leading to shoola, shotha and stabdhata in the
sandhis. The features of Amavata are similar to Rheumatoid Arthritis, an
autoimmune disorder which causes chronic inflammation and symmetric, peripheral
polyarthritis. Rheumatoid Arthritis is one of the leading causes of YLD (Years
lived with Disability) at global levels. The
shamana chikitsa is expected to provide adequate results for this chronic
disease. Shallakiadi Yoga contain ingredients which are locally available, easy
to prepare and possess deepana, amapachaka, sothahara and shoolahara
properties. The ingredients of both formulations have gunas antagonist to ama,
which are very much required in the management of Amavata. Shallakiyaadi yoga 3 tablets thrice a day will be given after food. This medicine will be given for 15 days. With a view that the selected the aims to evaluate the combined
effectiveness of Shallakiadi Yoga in Amavata.
|