| CTRI Number |
CTRI/2024/09/073502 [Registered on: 06/09/2024] Trial Registered Prospectively |
| Last Modified On: |
30/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To determine the effect of Guduchiarka in Rheumatoid Arthritis |
|
Scientific Title of Study
|
Effect of Guduchiarka in Rheumatoid arthritis |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Divya K |
| Designation |
PG Scholar, Department of Kayachikitsa |
| Affiliation |
Poomulli Neelakantan Namboodiripad Memorial Ayurveda Medical College and Hospital |
| Address |
Department of Kayachikitsa
Poomulli Neelakantan Namboodiripad Memorial Ayurveda Medical College and Hospital, Cheruthuruthy, Thrissur
Thrissur
KERALA
679531
India |
| Phone |
6238299356 |
| Fax |
|
| Email |
divyakmm92@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ratheesh P |
| Designation |
HOD and Professor , Department of Kayachikitsa |
| Affiliation |
Poomulli Neelakantan Namboodiripad Memorial Ayurveda Medical College and Hospital |
| Address |
Department of Kayachikitsa
Poomulli Neelakantan Namboodiripad Memorial Ayurveda Medical College and Hospital, Cheruthuruthy, Thrissur
Thrissur
KERALA
679531
India |
| Phone |
9846889793 |
| Fax |
|
| Email |
drrpnair07@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vinitha C |
| Designation |
Associate Professor, Department of Kayachikitsa |
| Affiliation |
Poomulli Neelakantan Namboodiripad Memorial Ayurveda Medical College and Hospital |
| Address |
Department of Kayachikitsa
Poomulli Neelakantan Namboodiripad Memorial Ayurveda Medical College and Hospital, Cheruthuruthy, Thrissur
Thrissur
KERALA
679531
India |
| Phone |
9497062425 |
| Fax |
|
| Email |
drvinithasujith@gmail.com |
|
|
Source of Monetary or Material Support
|
| Poomulli Neelakantan Namboodiripad Memorial Ayurveda Medical College and Hospital, Cheruthuruthy,Thrissur - 679531, Kerala - India |
|
|
Primary Sponsor
|
| Name |
Divya K |
| Address |
PG Scholar
Department of Kayachikitsa
Poomulli Neelakantan Namboodiripad Memorial Ayurveda Medical College and Hospital, Cheruthuruthy,Thrissur - 679531 |
| 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 |
| DivyaK |
Poomulli Neelakandan Namboodiripad memorial Ayurveda Medical College and Hospital |
Department of Kayachikitsa
Poomulli Neelakandan Namboodiri Memorial Ayurveda Medical College and Hospital, Cheruthuruthy,Thrissur -679531, Kerala
Thrissur
KERALA |
6238299356
divyakmm92@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee PNNM Ayurveda Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M069||Rheumatoid arthritis, unspecified. Ayurveda Condition: VATARAKTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Guduchi arka, Reference: Arka Prakasha, Route: Oral, Dosage Form: Arka, Dose: 24(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -750 mg of Sunti churna and 24 ml of water ), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Participants fulfilling the diagnostic criteria
Age between 18 - 60 years
Participants irrespective of gender
Participants willing to give informed consent |
|
| ExclusionCriteria |
| Details |
Pregnant and Lactating women
Known case of malignancy
Known case of systemic illness
Known case of Gouty arthritis, psoriatic arthritis and osteoarthritis
Under medication for Rheumatoid arthritis
Complication of Rheumatoid arthritis |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Tenderness
Morning Stiffness
Swelling
Visual Analogue Scale |
Assessment on 0th day, 16th day and 31st day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Rheumatoid Factor
Erythrocyte Sedimentation Rate
Disease Activity Score (DAS-28)
Quality of Life (Indian Health Assessment Questionnaire -Disability Index) |
Assessment on 0th day and 31st day |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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 3 |
|
Date of First Enrollment (India)
|
30/09/2024 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The aim of the study is to determine the effect of Guduchi arka in Rheumatoid arthritis. This will be an interventional study with pre, intermediate and post assessment conducted in the OPD of Poomulli Neelakantan Namboodiripad Memorial Ayurveda Medical College and Hospital, Cheruthuruthy. Twenty four participants will be selected on the basis of inclusion criteria will be evaluated clinically in detail using a pre-designed case proforma. 24 ml of Guduchi arka with 750 mg of Sunti churna and 24 ml of boiled and cooled water is given twice daily after food for a period of 30 days. Evaluation will be done on 0th, 16th and 31st day and changes in parameters will be recorded. The primary outcome measures will be tenderness, swelling, morning stiffness and Visual Analogue Scale which will be assessed on 0th,16th and 31st day and secondary outcomes like Rheumatoid Factor, Erythrocyte Sedimentation Rate , Disease Activity Score and Quality of Life will be assessed on 0th and 31st day. The results obtained will be statistically analysed . |