CTRI Number |
CTRI/2023/02/049968 [Registered on: 22/02/2023] Trial Registered Prospectively |
Last Modified On: |
21/02/2023 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Ayurveda |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
a comparative clinical study of erandbeejadi gutika pippalyadi gana kashaya and ruksha pottali sweda in the management of amavata |
Scientific Title of Study
|
a comparative clinical study to evaluate the efficacy of erandbeejadi gutika pippalyadi gana kashaya and ruksha pottali sweda in the management of amavata |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
nil |
ClinicalTrials.gov |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
BYOMESH UPADHYAY |
Designation |
PG Scholar Department of Kayachikitsa |
Affiliation |
Shri Narayana Prasad Awasthi Government Ayurved College Raipur CHHATTISGARH |
Address |
OPD Number 2 and 18 , Department of kayachikitsa Shri Narayana Prasad Awasthi Government Ayurved College Raipur CHHATTISGARH
492010
Raipur CHHATTISGARH 492010 India |
Phone |
7566819731 |
Fax |
|
Email |
Upadhyaybyomesh@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
DrAruna Ojha |
Designation |
Proffesor in Department of Kayachikitsa |
Affiliation |
Shri Narayana Prasad Awasthi Government Ayurved College Raipur CHHATTISGARH |
Address |
opd no 2 and 18 Department of Kayachikitsa Shri Narayana Prasad Awasthi Government Ayurved College Raipur CHHATTISGARH
492010
Raipur CHHATTISGARH 492010 India |
Phone |
9424401858 |
Fax |
|
Email |
arunaojha90@gmail.com |
|
Details of Contact Person Public Query
|
Name |
DrRashmi Diwan |
Designation |
Lecturer in Department of Kayachikitsa |
Affiliation |
Shri Narayana Prasad Awasthi Government Ayurved College Raipur CHHATTISGARH |
Address |
Department of Kayachikitsa Shri Narayana Prasad Awasthi Government Ayurved College Raipur CHHATTISGARH
492010
Raipur CHHATTISGARH 492010 India |
Phone |
9770933579 |
Fax |
|
Email |
rashmi.diwan3@gmail.com |
|
Source of Monetary or Material Support
|
Department of Kayachikitsa Shri Narayana Prasad Awasthi Government Ayurved College Raipur CHHATTISGARH
|
|
Primary Sponsor
|
Name |
Department of Kayachikitsa Shri Narayan Prasad Awasthi Govt. Ayurved College Raipur CHHATTISGARH |
Address |
Shri Narayan Prasad Awasthi Government Ayurved College Raipur CHHATTISGARH
|
Type of Sponsor |
Other [Government Ayurved College Raipur] |
|
Details of Secondary Sponsor
|
Name |
Address |
Department of Kayachikitsa Shri Narayan Prasad Awasthi Govt Ayurved College Raipur CHHATTISGARH |
Department of Kayachikitsa Shri Narayana Prasad Awasthi Government Ayurved College Raipur CHHATTISGARH
492010 |
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Byomesh Upadhyay |
Shri Narayan Prasad Awasthi Government Ayurved College Raipur CHHATTISGARH |
opd no 2 and 18 ipd in the department of kayachikitsa at Shri Narayan Prasad Awasthi Government Ayurved College Raipur CHHATTISGARH
492010 Raipur CHHATTISGARH |
7566819731
Upadhyaybyomesh@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
INSTITUTIONAL ETHICS COMMITTEE GOVERNMENT AYURVED COLLEGE RAIPUR (C.G.) 492010 |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition:M059||Rheumatoid arthritis with rheumatoid factor, unspecified. Ayurveda Condition: AMAVATAH, |
|
Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: pippalyadi gana kashaya, Reference: shushrut samhita, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: - | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: erandbeejadi gutika, Reference: yogaratnakar amavata adhikar, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(g), Frequency: qid, Bhaishajya Kal: Pragbhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: ushan jal), Additional Information: - |
|
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
it is based on Clinical signs and symptoms mentioned in ayurvedic and modern classics, especially pain swelling, and stiffness.
Health Assessment Questionnaire for RA
Visual Analog Scale (VAS)
WOMAC Index
|
|
ExclusionCriteria |
Details |
1. Patients below 18 years and above 60 years of age will not be taken.
2. Patients who develop a secondary complication of RA e.g. pleuro-pericardial disease. severely damaged joint with bedridden patients and severe crippling deformities.
3. Patients having neoplasm of the spine, gout, ankylosing spondylitis, traumatic arthritis, and pyogenic osteomyelitis.
4. Patients suffering from paralysis, Liver cirrhosis, Liver failure, Hepatocellular or any carcinoma, and Ascites.
5. Patients having associated cardiac disease, pulmonary tuberculosis, uncontrolled diabetes mellitus, malignant hypertension, renal function impairment, etc.
6. Pregnant and lactating mother.
7. Patients who are taken steroids.
8. Other joint disorders like Gout, Osteoarthritis.
The patient mentioned above who is suffering from any severe disease will come under the category of exclusion.
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
Method of Concealment
|
Other |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
reduce the symptoms of amavata especially pain,swelling and stiffness(rheumatoid arthritis) |
reduce the symptoms of amavata in 8 weeks |
|
Secondary Outcome
|
Outcome |
TimePoints |
improve the quality of life |
90 days |
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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 1/ Phase 2 |
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
|
In the 7th century, acharya Madhava emphasizes
that it is a systemic disorder involving digestive and metabolic mechanisms.in text described the main symptoms of Amavata clearly.
They can be classified under the following headings: -Pratyatma Lakshana:-
Sandhi Shoola, Sandhi Shotha, and Stabdhata.In modern science, It is correlated to rheumatoid arthritis (RA). It is a chronic autoimmune
inflammatory systemic disease. In this, the body’s immune system attacks its tissue, which affects synovial joints with extra-articular manifestations. In
this bilateral, peripheral joints are involved symmetrically. Primary symptoms of RA are joint inflammation, pain, loss of
function, and eventual joint destruction and deformity. For the present study, on amavata as shaman therapy, the medicine I choose is a suitable natural product that will make it
possible for patients to live a high quality of life along with reducing the specific
symptoms of pain, swelling & stiffness. These medicines have properties of deepan,pachan,shulahar & shothahar without any side effects in our textes. Considering the
magnitude of amavata, I am doing a clinical & comparative study of Erandbeejadi
Gutika, Pippalayadi Gana Kashaya & Ruksha pottali Sweda in the management of
Amavata. the volunteers will be informed about the study protocol. willing participants will be randomly selected as per the coin method. clinical research format will be prepared and validated before the study approval will be taken from the IEC of the NPA government Ayurved college and hospital, Raipur C.G.and CTRI registration will be done. after selection, each participant will be tasted individually and selected according to the selection criteria. Sixty patients
of Amavata will be selected from Kayachikitsa OPD and IPD Shrihri NPA government Ayurved college and
hospital, Raipur C.G. The case selection was in regards to age, sex, occupation, and socio‑economic conditions. Both acute and chronic phases of Amavata
patients were taken for the study, following the ACR criteria for diagnosing RA in modern medicine and the clinical features of Amavata described in
Madhava Nidana. The present study
is a single-center, open-labeled randomized (coin method) clinical trial. A total of 60
clinically diagnosed and registered patients of Amavata were divided randomly
by coin method into two groups. Each
group will have 30 patients. Group A: 30
clinically diagnosed patients of Amavata will be treated with erandbeejadi
gutika two tablets(each 500 mg) four
times in a day with lukewarm water before meal for 90 days along with modified
ruksha sweda.Group B: 30
clinically diagnosed patients of Amavata were treated with pippalyadi gana
kashaya 50 ml two times n a day as
patient Agni Bala aftAgni Balafor 90 days along with modified ruksha sweda.modified ruksha pottali sweda :-Ingredient:- Baluka (50%) +Shunthi+Yava+Saindhav Lavan+Methi+Shatpushpa
(50%).
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