| CTRI Number |
CTRI/2024/06/069098 [Registered on: 18/06/2024] Trial Registered Prospectively |
| Last Modified On: |
17/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda Other (Specify) [Curative] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Ayurveda Formulation in Hyperuricemia |
|
Scientific Title of Study
|
Combined effect of Amritaguggulu and Amritashadangam Kashayam in the management of Hyperuricemia a pre test post test design |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SILPA M R |
| Designation |
PG Scholar |
| Affiliation |
Vaidyaratnam Ayurveda College Ollur |
| Address |
Department of Kayachikitsa Vaidyaratnam Ayurveda College Ollur Thrissur Department of Kayachikitsa Vaidyaratnam Ayurveda College Ollur Thrissur Thrissur KERALA 680306 India |
| Phone |
9995478572 |
| Fax |
|
| Email |
silpaachanjal@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr PV GIRI |
| Designation |
Professor Department of Kayachikitsa |
| Affiliation |
Vaidyaratnam Ayurveda College, Ollur |
| Address |
Department of Kayachikitsa Vaidyaratnam Ayurveda College
Thaikkattussery
Ollur
Thrissur
Thrissur KERALA 680306 India |
| Phone |
9447527366 |
| Fax |
|
| Email |
doctorviswagiri@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr PV GIRI |
| Designation |
Professor Department of Kayachikitsa |
| Affiliation |
Vaidyaratnam Ayurveda College, Ollur |
| Address |
Department of Kayachikitsa Vaidyaratnam Ayurveda College
Thaikkattussery
Ollur
Thrissur
Thrissur KERALA 680306 India |
| Phone |
9447527366 |
| Fax |
|
| Email |
doctorviswagiri@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vaidyaratnam Ayurveda College Ollur Thrissur 680306 pin Kerala India |
|
|
Primary Sponsor
|
| Name |
SILPA M R |
| Address |
Vaidyaratnam Ayurveda College Thaikkattussery Ollur Thrissur Kerala 680306 Pin India |
| 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 SILPA MR |
Vaidyaratnam Ayurveda College Ollur |
OPD Department of Kayachikitsa Vaidyaratnam Ayurveda College Ollur Thrissur 680306 Pin Thrissur KERALA |
9995478572
silpaachanjal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Vaidyaratnam Ayurveda College Ollur |
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 | Classical | | (1) Medicine Name: Amrita Guggulu, Reference: Chakradatta, Route: Oral, Dosage Form: Guggulu , Dose: 1.5(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 1 Months, anupAna/sahapAna: No, Additional Information: -Given with Amritashadangam Kashayam(2) Medicine Name: Amritashadangam Kashayam, Reference: Chikitsamanjari, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 45(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 1 Months, anupAna/sahapAna: No, Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Participants without symptoms and with symptoms like pain and or tenderness of joint and
serum uric acid level greater than 6.8mg/dL to 12mg/dl in males and greater than 5.7mg/dL to 12mg/dl in females
will be included
2.Participants aged between 30-60 years will be included
|
|
| ExclusionCriteria |
| Details |
1.Participants with secondary Gout, pre diagnosed cases of Rheumatoid Arthritis.
2.Participants taking other medication for hyperuricemia.
3.Severe Systemic illness such as Chronic Kidney Disease, Diabetes Mellitus.
4.Chronic Cardiac Disease.
5.Pregnant women and lactating mother.
6.Participants having completed any other trial with in past 6 months.
7.Participants intaking alcohol |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Serum Uric acid |
Before After and Follow up 0th, 31st, 45th |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Subjective Parameters Tenderness Pain Ama |
Before after & on Follow up 0th, 31st, 45th |
|
|
Target Sample Size
|
Total Sample Size="31" Sample Size from India="31"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/07/2024 |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Data are available indefinitely at (Link to be included www.hyperuricemia.in).
- For how long will this data be available start date provided 01-04-2026 and end date provided 01-04-2031?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Hyperuricemia is defined as a serum urate concentration of >6.8mg /dl for men and >5.7mg/dl for women. Worldwide, the prevalence of hyperuricemia has increased substantially in recent decades. The most well-known disease induced by hyperuricemia is gout. However, many studies have reported that hyperuricemia also plays an important role in cardiac-kidney vascular system disease and metabolic syndrome. Hence, by defining the gravity of the condition based on the existing facts, the condition requires proper understanding followed by a strong and rational approach. The symptoms of Hyperuricemia and Gouty arthritis are similar to vatharakta, a disease explained in classical Ayurvedic textbooks. Since it is an outcome of impaired uric acid metabolism, A drug having agnideepana, amapachana, pithahara and raktaprasadana property is effective in this clinical condition. The study drug Amrita Guggulu described in Chakradatta Vatarakta chikitsa, Amritashadangam kashayam described in Chikitsamanjari Vatarakta chikitsa are widely used by Ayurvedic practitioners of kerala for treating hyperuricemia and its complications.Since the condition is having high prevalence even now, it is need of the hour to have a safe and effective treatment for the condition.Since prevention is better than cure, managing modifiable risk factors plays a key role in medical practice. Even though the incidence and prevalence of Gouty arthritis, Uric acid nephrolithiasis and Acute Uric acid nephropathies are increasing in the past two decades, the management of the risk factor is still unsatisfactory in terms of the community- wide lack of knowledge about the risk factor, availability of a cost effective and effective medicament. |