| CTRI Number |
CTRI/2024/12/078823 [Registered on: 31/12/2024] Trial Registered Prospectively |
| Last Modified On: |
13/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical Study of Mudgaparni on Vatarakta |
|
Scientific Title of Study
|
Phytochemical Study and Therapeutic Evaluation of Mudgaparni (Vigna trilobata Linn.) for its Vataraktahara action |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Manaswini Singh |
| Designation |
PG Scholar |
| Affiliation |
Ayurvedic and Unani Tibbia College and Hospital, Karol Bagh, New Delhi |
| Address |
Department of Dravyagunavigyan, Ayurvedic and Unani Tibbia College and Hospital,Karol Bagh
Central
DELHI
110005
India |
| Phone |
9910618725 |
| Fax |
|
| Email |
manaswinisingh1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Rajesh Sharma |
| Designation |
Professor |
| Affiliation |
Ayurvedic and Unani Tibbia College and Hospital |
| Address |
Department of Dravyaguna Vigyan Ayurvedic and Unani Tibbia College and Hospital Karol Bagh New Delhi
Central
DELHI
1100053
India |
| Phone |
9868092250 |
| Fax |
|
| Email |
rajsakshi.sharma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Rajesh Sharma |
| Designation |
Professor |
| Affiliation |
Ayurvedic and Unani Tibbia College and Hospital |
| Address |
Department of Dravyagunavigyan, Ayurvedic and Unani Tibbia College and Hospital, Karol Bagh
Central
DELHI
1100053
India |
| Phone |
9868092250 |
| Fax |
|
| Email |
rajsakshi.sharma@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ayurvedic and Unani Tibbia College and Hospital, Karol Bagh, New Delhi-110005 |
|
|
Primary Sponsor
|
| Name |
Ayurvedic and Unani Tibbia College and Hospital |
| Address |
Karol Bagh, New Delhi-110005 |
| Type of Sponsor |
Government medical college |
|
|
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 Manaswini Singh |
Ayurvedic and Unani Tibbia College and Hospital, Karol Bagh, New Delhi-110005 |
Ekal dravya OPD No.18, Ayurvedic and Unani Tibbia College and Hospital, Karol Bagh, New Delhi-110005
Central
DELHI |
9910618725
manaswinisingh1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ayurvedic and Unani Tibbia College and Hospital Institutional Ethics Committee |
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: MUDGAPARNI, Reference: RAJNIGHANTU NIGHANTU DHANWANTRI NIGHANTU, Route: Oral, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: LUKEWARM WATER), Additional Information: PANCHANGA OF MUDGAPARNI |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Patient of either sex belong to age group 20-60 years.
2 Diagnosed cases of Vatarakta with classical symptoms such as Shula,Saruka shotha, Kandu, Vidaha, Sparshasahishnuta.
3 Serum Uric Acid level more than 7mg/dl for Male and more than 6mg/dl for Female.
4 Patient willing to participate in Trial and give written informed consent. |
|
| ExclusionCriteria |
| Details |
1 Serum Uric Acid level more than 10mg/dl.
2 Diagnosed cases of Inflammatory Joint Disorders such as Rheumatoid Arthritis, Osteoartritis, Psoriatic Arthritis.
3 Patients suffering from Chronic Renal Impairment, Chronic Respiratory Diseases, Hepatic Disease.
4 Pregnant and Lactating patients.
5 Patients taking Steroid therapy.
6 Patients taking any form of Medication for Hyperuricemia. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Serum Uric Acid level less than 6mg/dl will be considered as Healthy individuals |
3 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| For Assessing the effectiveness of treatment, the scoring pattern of Subjective & Objective parameters will be assessed before & after treatment |
Before & After Completion of Trial |
|
|
Target Sample Size
|
Total Sample Size="58"
Sample Size from India="58"
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)
|
14/01/2025 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
HYPERURICEMIA IS CHARACTERIZED BY RAISED SERUM URIC ACID LEVEL FOR MALES AND FEMALES 7mg/dl AND 6mg/dl RESPECTIVELY. IN AYURVEDA VATARAKTA IS THE CLINICAL CONDITION WHOSE CLASSICAL FEATURES ARE SHULA, SARUKA SHOTHA, RAGA, KANDU, VIDAHA, SPARSHASAHISHNUTA ALONG WITH ELEVATED SERUM URIC ACID LEVELS. MUDGAPARNI (VIGNA TRILOBATA LINN.) IS DOCUMENTED AS VATARAKTAHARA BY RAJA NIGHANTU AND DHANVANTARI NIGHANTU. HYPERURICEMIA CAN LEAD TO SOME SERIOUS COMPLICATIONS SUCH AS GOUTY ARTHRITIS, NEPHROLITHIASIS ETC. HENCE, MUDGAPARNI AS A SAFE, COST EFFECTIVE, EASILY AVAILABLE AND NUTRITIVE SOLUTION SHOULD BE EXPLORED FOR ITS VATARAKTAHARA ACTION AND AS ANTI-HYPERURICEMIC EFFECT. AS TILL DATE NO STANDARD DRUG IS IDENTIFIED TO PREVENTS RECURRENCE OF HYPERURICEMIA EPISODES. |