| CTRI Number |
CTRI/2021/08/035463 [Registered on: 05/08/2021] Trial Registered Prospectively |
| Last Modified On: |
05/08/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of trutyadi churna in amavata with special reference to rheumatoid arthritis. |
|
Scientific Title of Study
|
A clinical study to evaluate the therapeutic effect of trutyadi chuna in 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 VISHNUPRIYA SEETHARAM |
| Designation |
PG scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara college of ayurveda kuthpady,udupi |
| Address |
Sri dharmasthala manjunatheswara college of ayurveda, kuthpady, Udupi,Karnataka
Udupi
KARNATAKA
574118
India |
| Phone |
9400848984 |
| Fax |
|
| Email |
vishnupriyaseetharam@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR VEERAKUMARA K |
| Designation |
Associate Professor |
| Affiliation |
shri Dharamasthala Manjunatheshwara college of ayurveda kuthpady,udupi |
| Address |
Department of Pg studies kayachikitsa sri dharamsthala manjunatheswara kuthpady,Udupi,Karnataka
Udupi
KARNATAKA
574118
India |
| Phone |
9743490753 |
| Fax |
|
| Email |
khadiravana@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR VISHNUPRIYA SEETHARAM |
| Designation |
PG Scholar |
| Affiliation |
sri dharmasthala manjunatheswara college of ayurveda kuthpady,udupi |
| Address |
Department of Pg studies in kayachikitsa sri dharmasthala manjunatheswara kuthpady, Udupi, karnataka
Udupi
KARNATAKA
574118
India |
| Phone |
9400848984 |
| Fax |
|
| Email |
vishnupriyaseetharam@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri dharmasthala manjunatheswara college of Ayurveda and hospital kuthpady, udupi, karnataka |
|
|
Primary Sponsor
|
| Name |
DR VISHNUPRIYA SEETHARAM |
| Address |
Sri dharmasthala manjunatheswara college of Ayurveda and hospital kuthpady,udupi,karnataka |
| Type of Sponsor |
Other [] |
|
|
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 VISHNUPRIYA SEETHARAM |
Shri Dharamasthala Manjunatheshwara college of ayurveda kuthpady,udupi |
Department of Pg studies in kayachikitsa Sri dharmasthala manjunatheswara college of Ayurveda and hospital kuthpady,Udupi,karnataka
Udupi
KARNATAKA |
9400848984
vishnupriyaseetharam@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL CLEARANCE COMMITTEE- HUMAN |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M049||Autoinflammatory syndrome, unspecified. Ayurveda Condition: AMAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: TRUTYADI CHURNA, Reference: BRIHAT NIGHANTU RATNAKARA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 4000(mg), Frequency: tds, Bhaishajya Kal: Antarabhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: SITA SADHITA JALA), Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
ACR 2010 CRITERIA FOR RHEUMATOID ARTHERITIS.
BOTH SERO POSITIVE AND SERO NEGATIVE CASES OF RA FACTOR.
PATIENTS OF AMAVATA SUFFERING FROM 1 TO 10 YEARS OF DURATION. |
|
| ExclusionCriteria |
| Details |
PATIENTS OF AGE GROUP LESS THAN 18 AND MORE THAN 70.
PREGNANT AND LACTATING MOTHERS OR THOSE ATTEMPTING TO CONCEIVE.
PATIENTS OF SEVERE STRUCTURAL DEFORMITIES WILL BE EXCLUDED FROM THE STUDY.
PATIENTS OF RA WITH ANY SYSTEMIC ILLNESS (HEPATIC FAILURE, RENAL FAILURE, ISCHEMIC HEART DISEASE, MALIGNANCY ETC).
PATIENTS SUFFERING FROM CONNECTIVE TISSUE DISORDERS OTHER THAN RA. |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
ASSESMENT OF PAIN [TIME FRAME:BASELINE AND DAY 14] BY VISUAL ANALOG SCALE
SWOLLEN JOINT COUNT OVER TIME [TIME FRAME: BASELINE AND DAY 14]
TENDER JOINT COUNT OVER TIME [BASELINE AND DAY 14]
STIFFNESS OF JOINTS ASSESSED OVER TIME WITH LIKERT SCALE[ TIME FRAME:BASELINE AND DAY 14]
CHANGE IN AVERAGE RANGE OF MOVEMENTS OF AFFECTED JOINTS OVER TIME [TIME FRAME : BASELINE AND DAY 14]
CHANGE FROM BASELINE IN DISEASE ACTIVITY SCORE 28 [TIME FRAME : BASELINE AND DAY 14] |
BASELINE AND DAY 14] |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
ERYTHROCYTE SEDIMENTATION RATE OVER TIME [TIME FRAME: BASELINE AND DAY 14]
HB%
CHANGE FROM BASELINE IN INDIAN VERSION OF HEALTH ASSESSMENT QUESTIONNAIRE DISABILITY INDEX [TIME FRAME: BASELINE AND DAY 14] |
BASELINE AND DAY 14 |
|
|
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" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/08/2021 |
| 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) |
Open to Recruitment |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A Current study will be in single arm clinical study to evaluate the effect of trutyadi churna in amavata with special reference to rheumatoid arthritis. in this study, minimum 20 patients diagnosed with amavata will be chosen. The trutyadi churna will be given as 500mg capsules (8 capsules TID) after food. Anupana will be sita sadhita jala. The drug is given for 14 days followed by a follow up period of 14 days. |