| CTRI Number |
CTRI/2020/10/028746 [Registered on: 29/10/2020] Trial Registered Prospectively |
| Last Modified On: |
28/10/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Therapeutic role of Ayurvedic interventions in Amavata(Rheumatoid arthritis) with special reference to gut microbiota |
|
Scientific Title of Study
|
To evaluate the safety and efficacy of Ayurvedic Interventions and Analysis of Gut Flora in the cases of Amavata vis-Ã -vis 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 |
OP SINGH |
| Designation |
PROFESSOR |
| Affiliation |
Institute of Medical Sciences, Banaras Hindu University, Varanasi |
| Address |
Department of Kayachikitsa Faculty of Ayurveda
Institute of Medical Sciences Banaras Hindu University Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
09415818732 |
| Fax |
|
| Email |
singhopbhu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
OP SINGH |
| Designation |
PROFESSOR |
| Affiliation |
Institute of Medical Sciences, Banaras Hindu University, Varanasi |
| Address |
Department of Kayachikitsa Faculty of Ayurveda
Institute of Medical Sciences Banaras Hindu University Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
09415818732 |
| Fax |
|
| Email |
singhopbhu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR AMRIT GODBOLE |
| Designation |
PhD SCHOLAR |
| Affiliation |
Institute of Medical Sciences, Banaras Hindu University, Varanasi |
| Address |
Department of Kayachikitsa Faculty of Ayurveda
Institute of Medical Sciences Banaras Hindu University Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
07408859248 |
| Fax |
|
| Email |
amritgodbole2@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sir Sunderlal Hospital, Banaras Hindu University, Varanasi |
|
|
Primary Sponsor
|
| Name |
AMRIT GODBOLE |
| Address |
DEPARTMENT OF KAYACHIKITSA, FACULTY OF AYURVEDA, INSTITUTE OF MEDICAL SCIENCES, BHU, VARANASI |
| Type of Sponsor |
Other [self] |
|
|
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 |
| DR AMRIT GODBOLE |
SIR SUNDERLAL HOSPITAL |
BANARAS HINDU UNIVERSITY VARANASI
Varanasi
UTTAR PRADESH |
07408859248
amritgodbole2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M068||Other specified rheumatoid arthritis. Ayurveda Condition: AMAVATAH, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
SHATYADI KASHAYA GHAN VATI |
AYURVEDIC HERBAL FORMULATION DOSE- 2VATI (EACH VATI 500MG) TDS
DURATION OF THERAPY- 90DAYS
ROUTE- ORAL |
| Comparator Agent |
VIRECHANA FOLLWOWED BY SHATYADI KASHAYA GHANA VATI |
Deepana- pachana with Trikatu churna 3gm bd with luke warm water for 5days. (Poorvakarma) : Sneha Pana with Tila Tail for 3-7 days(as per the koshtha and agnibala) till the appearance of samyak snigdha lakshanas. Complete rest and Laghu, Ushna ahara like Rice Porridge etc for 3 days. Patient is monitored for the Samyak Virechana Lakshanas, antaki, vaigiki and laingiki shuddhi will be examined. This is followed by Samsarjana Krama for 3-7 days as per the koshtha shuddhi lakshanas. ): After completion of the samsarjana karma (5-6 days), the patients of Group B will be given the shatyadi kashaya ghan vati (2tab TDS) for the rest of trial period. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients of age group between 30-50 yrs willing to participate for the trial with a diagnosis of rheumatoid arthritis using the ACR 2010.
2.Diagnosed cases of Amavata based on symptoms and signs described in Madhav Nidana.
3.Patients with H/O more than 1year with established disease.
4.Sero positive and Seronegative both cases are included.
|
|
| ExclusionCriteria |
| Details |
1.Patients not willing to participate.
2.Patients with a short history of less than a year.
3.Patients having severe deformities.
4.Patients of Rheumatic Arthritis, Gouty Arthritis, Infective Arthritis, Osteoarthritis.
5.HIV, Tuberculosis, Hypertension, D.M., and other systemic problems.
6.Pregnant & lactating women
7.Patients with major complications such as extra-articular manifestations are also excluded.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| IMPROVED DAS28 SCORE AND EULAR SCORE |
AT THE TIME OF REGISTRATION, AT THE TIME OF 1ST FOLLOW-UP AT 30DAYS, AT 2ND FU AT 60DAYS, AT 3RD FU AT 90DAYS. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| ANTI CCP, IL 17, IL10 |
AT THE TIME OF REGISTRATION AND AT THE COMPLETION OF TRIAL |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
N/A |
|
Date of First Enrollment (India)
|
02/11/2020 |
| 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="4"
Days="29" |
|
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
|
1.
To reflect an overview of the concept of Amavata vis-Ã -vis rheumatoid arthritis. To review
the role of gut flora in the pathogenesis of rheumatoid arthritis and
characterize the facultative aerobic bacteria’s in the gut flora in RA patients
with respect to control. To study the effect of Virecana Karma and Shatyadi
kashaya Ghana Vati on subjective and objectives parameters in the cases of rheumatoid arthritis. To compare the efficacy
of Virecana
Karma and Shatyadi kashaya Ghana Vati in the cases of rheumatoid arthritis. To
study the effect of Virecana Karma and drug over pro and anti-inflammatory markers
at the baseline and at the end.
·
|