| CTRI Number |
CTRI/2024/10/075757 [Registered on: 23/10/2024] Trial Registered Prospectively |
| Last Modified On: |
22/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Rasnadi kwath and Shampakadi Kwath in Vatrakta (hyperuricemia). |
|
Scientific Title of Study
|
An open randomized comparative clinical study of Rasnadi Kwath and Shampakadi kwath in the management of Vatrakta with special reference to hyperuricemia. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mohan Bhagwan Rajput |
| Designation |
post graduate resident |
| Affiliation |
APMs Ayurved Mahavidyalaya Sion Mumbai |
| Address |
Department of kayachikitsa floor no.4 APMs Ayurved Mahavidyalaya Sion near sion railway station Sion Mumbai 400022
Mumbai
MAHARASHTRA
400022
India |
| Phone |
7028484876 |
| Fax |
|
| Email |
mohanbhagwanrajput@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vidya Rao |
| Designation |
Associate Professor |
| Affiliation |
APMs Ayurved Mahavidyalaya Sion Mumbai |
| Address |
Department of kayachikitsa 4th floor
APMs Ayurved Mahavidyalaya Sion near sion railway station Sion Mumbai 400022
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9820725950 |
| Fax |
|
| Email |
drvidyap@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vidya Rao |
| Designation |
Associate Professor |
| Affiliation |
APMs Ayurved Mahavidyalaya Sion Mumbai |
| Address |
Department of kayachikitsa 4th floor
APMs Ayurved Mahavidyalaya Sion near sion railway station Sion Mumbai 400022
MAHARASHTRA
400022
India |
| Phone |
9820725950 |
| Fax |
|
| Email |
drvidyap@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Ayurvidya Prasarak Mandal, APMs Ayurved mahavidyalaya sion, Mumbai ,Maharashtra,India 400022 |
|
|
Primary Sponsor
|
| Name |
Mohan Bhagwan Rajput |
| Address |
APMs Ayurved Mahavidyalaya sion near sion railway station Sion Mumbai 400022 |
| 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 Mohan Bhagwan Rajput |
APMs Ayurved Mahavidyalaya and seth R V Ayurved Hospital Sion Mumbai |
Floor no 4 department of kayachikitsa Ayurved Mahavidyalaya Sion near sion railway station Sion Mumbai 400022
Mumbai
MAHARASHTRA |
7028484876
mohanbhagwanrajput@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| APMs Ayurved Mahavidyalaya Sion IEC |
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: Rasnadi Kwath, Reference: vrund madhav 23/16, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: Erand Tail), Additional Information: | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Shampakadi Kwath, Reference: Bhaishajya ratnavali 27/9, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: Erand Tail), Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1) All genders will be included
2) Age group -20 to 70 year.
3) All the patients clinically diagnosed as Vatarakta.
4) Patient having uric acid level :- Male 7.0 mg/dl to 12.0 mg/ dl, Female 6.0 to 12 mg/ dl. |
|
| ExclusionCriteria |
| Details |
1. Patient with Renal failure.
2. Pregnant and Lactating mothers.
3. Patient with known case of HIV and HbsAg |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Serum uric acid levels |
21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. joint pain
hypersensitivity at joints
Joint stiffness
restricted joint movements
redness at joints locally
swelling around joints
burning sensation at joints |
21 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 4 |
|
Date of First Enrollment (India)
|
05/11/2024 |
| 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 - NO
|
|
Brief Summary
|
Conventional treatment for control of hyperuricaemia according to modern science consist of range of
analgesics like opioid analgesics, NSAIDS, Cox inhibitor and xanthine oxidase inhibitor.
However, prolonged utilization of these medications can result in adverse effects like drug dependency,
Gastric irritation, Renal damage.Control of hyperuricaemia is one part of treatment of gout, so making a
comprehensive treatment approach is essential which can be achieved through the Ayurveda.
At this present time Ayurveda gains the ground, as most of ayurvedic medicines are herbal
preparations with minimal or no hazardous side effects. So the thought of exploring a drug which is
having properties to reduce signs and symptoms of Vatarakta and may lower uric acid level as well,
Hence, this clinical research is taken.
Out of many medicines described in texts for the treatment of Vatarakta, Rasnadi kwath has been
selected and planned to use judiciously. It is explained in the texts, that oral administration of Rasnadi kwath for 21 days gives
relief from pain, stiffness, inflammation, swelling and other symptoms of Vatarakta, Which are seen due
to vitiation of rakta |