| CTRI Number |
CTRI/2022/07/044300 [Registered on: 25/07/2022] Trial Registered Prospectively |
| Last Modified On: |
22/07/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Amritadhi Kwath In Gout |
|
Scientific Title of Study
|
An etiopathological study of vatarakta w.s.r. To Gout And therapeutical study of amritadhi kwath |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Hemlata Meena |
| Designation |
PG Scholar |
| Affiliation |
Madan mohan Malviya Government Ayurved |
| Address |
PG Department Of Rog Nidan Evum Vikriti Vigyan Madan mohan Malviya Government Ayurved College Ambamata ,radaji circle,Udaipur, rajasthan
Udaipur
RAJASTHAN
313001
India |
| Phone |
8003049615 |
| Fax |
|
| Email |
hemlatameena321@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pankaj Marolia |
| Designation |
Professor & HOD |
| Affiliation |
Madan mohan Malviya Government Ayurved |
| Address |
Madan mohan Malviya Government Ayurved College Ambamata ,radaji circle,Udaipur, rajasthan
Udaipur
RAJASTHAN
313001
India |
| Phone |
9413193101 |
| Fax |
|
| Email |
pankajmarolia@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pankaj Marolia |
| Designation |
Professor & HOD |
| Affiliation |
Madan mohan Malviya Government Ayurved |
| Address |
Madan mohan Malviya Government Ayurved College Ambamata ,radaji circle,Udaipur, rajasthan
Madan mohan Malviya Government Ayurved College Ambamata ,radaji circle,Udaipur, rajasthan
Udaipur
RAJASTHAN
313001
India |
| Phone |
9413193101 |
| Fax |
|
| Email |
pankajmarolia@gmail.com |
|
|
Source of Monetary or Material Support
|
| Madan Mohan Malviya Government Ayurved College,Udaipur |
|
|
Primary Sponsor
|
| Name |
Madan mohan Malviya Government Ayurved College |
| Address |
Madan mohan Malviya Government Ayurved College Ambamata ,radaji circle,Udaipur, rajasthan |
| 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 Hemlata Meena |
Madan Mohan Malviya Government Ayurved College |
OPD NO. 2
PG Department Of Rog Nidan Evum Vikriti Vigyan Associated Hospitals Of Madan Mohan Malviya Government Ayurveda College Udaipur Rajasthan
Udaipur
RAJASTHAN |
8003049615
hemlatameena321@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee ,Madan mohan Malviya Government Ayurved College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M205||Other deformities of toe(s) (acquired). Ayurveda Condition: VATARAKTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Amritadhi kwath, Reference: chakradutt chikitsa, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: nil |
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.The Patients having clinical sign & symptoms of
vatarakta /gout.
2.Gout patients with uric acid level more than this
normal range.(normal range 2.0 -8.5 mg/dl) |
|
| ExclusionCriteria |
| Details |
1. who are suffering from uncontrolled diabetes ,joints pathologies other than arthritis .
2.Other disease such as Paralysis,parkinsons disease & cancer patients.
3.The patients having complain more than 3 year duration. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Improvement in sign & symptoms of vatarakta.
2.Improvement in Uric acid level |
2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Improvement in sign & symptoms of vatarakta.
2.Improvement in Uric acid level |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
30/07/2022 |
| 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
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a clinical study to evaluate the therapeutic effect of Amritadhi kwath in vatarakta .it is a single arm study in which 30 patients will be administered with 40 ml of amritadhi kwath bd. |