| CTRI Number |
CTRI/2023/07/055433 [Registered on: 20/07/2023] Trial Registered Prospectively |
| Last Modified On: |
25/07/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of ayurvedic drug Divya Trighan in patients with increased uric acid. |
|
Scientific Title of Study
|
Efficacy of traditional Ayurvedic formulation (Divya Trighan) in patients with Hyperuricemia: a single-arm, open-label, prospective, observational study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anurag Sharma |
| Designation |
Ayurvedic Practitioner |
| Affiliation |
Patanjali Yog Gram |
| Address |
Patanjali Yoggram Haridwar, Uttarakhand-249405
Hardwar
UTTARANCHAL
249405
India |
| Phone |
7302254792 |
| Fax |
|
| Email |
clinical.investigator@prft.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anurag Sharma |
| Designation |
Ayurvedic Practitioner |
| Affiliation |
Patanjali Yog Gram |
| Address |
Patanjali Yoggram Haridwar, Uttarakhand-249405
Hardwar
UTTARANCHAL
249405
India |
| Phone |
7302254792 |
| Fax |
|
| Email |
clinical.investigator@prft.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anurag Sharma |
| Designation |
Ayurvedic Practitioner |
| Affiliation |
Patanjali Yog Gram |
| Address |
Patanjali Yoggram Haridwar, Uttarakhand-249405
Hardwar
UTTARANCHAL
249405
India |
| Phone |
7302254792 |
| Fax |
|
| Email |
clinical.investigator@prft.in |
|
|
Source of Monetary or Material Support
|
| Patanjali research institute governed by patanjali research foundation trust |
|
|
Primary Sponsor
|
| Name |
Patanjali Research Institute governed by Patanjali Research Foundation Trust |
| Address |
Patanjali Research Institute Near Patanjali Yogpeeth 1, NH 58
Haridwar, Uttarakhand 249405
Type of Sponsor Research institution
|
| Type of Sponsor |
Research institution |
|
|
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 Anurag Sharma |
Patanjali Wellness Center |
Patanjali Wellness Limited,
Near Patanjali Yogpeeth Phase 1, Bahadrabad
Hardwar
UTTARANCHAL
Hardwar
UTTARANCHAL |
8700567087
clinical.investigator@patanjali.res.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E790||Hyperuricemia without signs of inflammatory arthritis and tophaceous disease. Ayurveda Condition: VATARAKTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Divya Trighan, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Antarabhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: Lukewarm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. The subject with raised uric acid level in blood or urine (male: ≥ 8.5 mg/dl and female ≥ 7.3mg/dl)
2. Males or Females of age limit 18 to 60 years.
3. Patient agrees to provide informed consent.
4. Patient willing to participate in the study and ready to comply with study protocols.
5. No alcohol or drug dependency.
|
|
| ExclusionCriteria |
| Details |
1. Pregnancy or lactation, intent to become pregnant.
2. The subject with complications of pre-existing comorbidities or surgical intervention or undergone dialysis in last 3 month.
3. The subject with known history of uncontrolled DM and HTN.
4. The subject not willing to provide consent.
5. The subject not willing to comply with the protocol
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the change in Uric acid levels after treatment with Divya Trighan in patients with Hyperuricemia. |
Baseline, 4 weeks, 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| •Change in the Quality of life of patients with SF-36 questionnaire |
day 1,day 30,day 60 |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
31/07/2023 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
This study is a single arm,open-label, prospective, observational study.Participants will be enroled for 6 months.The primary outcome includes improvement in laboratory parameters after 2 months of interventions. Secondary outcomes include assessment of quality of life of the patient |