| CTRI Number |
CTRI/2024/07/071522 [Registered on: 29/07/2024] Trial Registered Prospectively |
| Last Modified On: |
10/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Role of herbal medicine in Gout disease |
|
Scientific Title of Study
|
A comparative clinical study of the effect of Siravedh and Gudaharitaki in the management of Vatarakta w.s.r. to Gout |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Prem Kumar |
| Designation |
PhD scholar and Assistant professor |
| Affiliation |
Postgraduate Institute of Ayurved, Dr.S.R.Rajasthan Ayurved University, Jodhpur |
| Address |
Postgraduate department of Shalya Tantra, Postgraduate Institute of Ayurved, Dr.S.R.Rajasthan Ayurved University, Jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
8005835979 |
| Fax |
|
| Email |
premrverma979@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof. Mahesh Dixit |
| Designation |
Principal and Head |
| Affiliation |
Madan Mohan Malviya Government Ayurved College, Udaipur (Rajasthan) |
| Address |
Postgraduate department of Shalya Tantra, Madan Mohan Malviya Government Ayurved College, Udaipur (Rajasthan)
Udaipur
RAJASTHAN
313001
India |
| Phone |
9714245459 |
| Fax |
|
| Email |
prof.maheshdixit@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prem Kumar |
| Designation |
PhD scholar and Assistant professor |
| Affiliation |
Postgraduate Institute of Ayurved, Dr.S.R.Rajasthan University, Jodhpur |
| Address |
Postgraduate department of Shalya Tantra, Postgraduate Institute of Ayurved, Dr.S.R.Rajasthan University, Jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
8005835979 |
| Fax |
|
| Email |
premrverma979@gmail.com |
|
|
Source of Monetary or Material Support
|
| Postgraduate Institute of Ayurved, Dr.S.R.Rajasthan Ayurved University, Jodhpur |
|
|
Primary Sponsor
|
| Name |
Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur |
| Address |
Postgraduate Institute of Ayurved,
Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University,
Nagaur road,
Karwad,Jodhpur
Rajasthan,
India,
Pin code 342037 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Prof Mahesh Dixit |
Principal & Head
Postgraduate department of Shalya Tantra,
Madan Mohan Malviya Government Ayurved College, Udaipur, Rajasthan.
Pincode 313001
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Prem Kumar |
Sanjeevani Ayurved Hospital |
Room no.161, Postgraduate Department of Shalya Tantra, Postgraduate Institute of Ayurved, Dr.S.R. Rajasthan Ayurved University, Jodhpur
Jodhpur
RAJASTHAN |
9950483008
premrverma979@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Madan Mohan Malviya Government Ayurved College, Udaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M109||Gout, unspecified. Ayurveda Condition: VATARAKTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: guda haritaki, Reference: sushrut samhita chikitsa sthan chapter 5/12 versus, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: -luke warm water), Additional Information: - | | 2 | Intervention Arm | Procedure | - | sirAvedhaH, सिरावेधः | (Procedure Reference: sushrut samhita chikitsa sthan chapter 5/12 and sushrut samhita shareer sthan chapter8/23 versus, Procedure details: For siravedh in the foot, patient will be in sitting position on the table/chair and foot will be on flat surface and a torniquet will be applied to just above the ankle joint (i.e. above the ksipra marma) and site will be properly cleaned with antiseptic solution. After that siravedh will be done in prominent vein by 24 no. sterile disposable needle at the site 2 angula (approx. 4cm) above the Ksipra marma i.e. dorsal venous network in dorsal venous arch in foot.Blood of bloodletting will be collected in a measuring jar. )
| | 3 | Comparator Arm | Procedure | - | sirAvedhaH, सिरावेधः | (Procedure Reference: sushrut samhita chikitsa sthan chapter 5/ 12 versus and sushrut samhita shareer sthan chapter 8/ 23 versus, Procedure details: Forsiravedh in the foot, patient will be in sitting position on the table/chair and foot will be on flat surface and a torniquet will be applied to just above the ankle joint (i.e. above the ksipra marma) and site will be properly cleaned with antiseptic solution. After that siravedh will be done in prominent vein by 24 no. sterile disposable needle at the site 2 angula (approx. 4cm) above the Ksipra marma i.e. dorsal venous network in dorsal venous arch in foot.Blood of bloodletting will be collected in a measuring jar. )
(1) Medicine Name: guda haritaki, Reference: sushrut samhita chikitsa sthan chapter 5 versus 12, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 5(g), Frequency: bd, Duration: 2 Months |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of classical sign and symptoms of Vatarakta (Gout)with serum uric acid level greater than 7mg/dl in males and 6mg/dl in females.
2. Age 16 to 70 years, of either sex.
3. Patients willing to undergo trial.
|
|
| ExclusionCriteria |
| Details |
1. Not willing to undergo trial.
2. Patients having other associated arthropathies.
3. Patients taking modern medicines like uricosuric or xanthine oxidase inhibitors.
4. Contraindication of Siravedh.
5. Patients suffering from any bleeding disorders, pregnancy, anemia, uncontrolled diabetes mellitus will be excluded from the study.
6. Existing or less than 2 weeks ago oral treatment with corticosteroids or colchicine
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| relief in sign and symptoms of Vatarakta (Gout), decrease level of Uric acid in Blood |
2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| relief in sign and symptoms of Vatarakta (Gout), decrease level of Uric acid in Blood |
3 months |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
16/08/2024 |
| 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="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
|
It is a Randomized, Prospective, Open label, Interventional comparative
clinical trial. Three groups have been made for the trial in which one of the group will receive Siravedh karma, second group will receive Gud Haritaki and third group will receive siravedha and Guda haritaki togetherly.
|