| CTRI Number |
CTRI/2023/01/049163 [Registered on: 24/01/2023] Trial Registered Prospectively |
| Last Modified On: |
23/01/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) |
| Study Design |
Other |
|
Public Title of Study
|
Effect of Shampakadi Kwatha in the management of Vatrakta w.s.r to Hyperuricemia |
|
Scientific Title of Study
|
A clinical study to evaluate the effect of Shampakadi Kwatha in the management of Vatrakta w.s.r. to Hyperuricemia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vijay Chaudhary |
| Designation |
Principal cum dean |
| Affiliation |
RGGPG Ayu Colllege Paprola HP |
| Address |
College Campus Admin block Principal room RGGPG Ayu College Paprola HP
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418130228 |
| Fax |
|
| Email |
drvijaychaudhary@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manik Soni |
| Designation |
Lecturer |
| Affiliation |
RGGPG Ayu. Colllege Paprola HP |
| Address |
Rajiv Gandhi Govt. Ayu. Post Graduate College and Hospital Paprola(HP) room no. 205 Kayachikitsa deptt. 1st floor ofAnatomy Block of Rajiv Gandhi Govt. Ayu. Post Graduate College and Hospital
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9816842425 |
| Fax |
|
| Email |
drmsony@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anu Devi |
| Designation |
P.G Scholar |
| Affiliation |
RGGPG Ayu. Colllege Paprola HP |
| Address |
Rajiv Gandhi Govt. Ayu. Post Graduate College and Hospital Paprola(HP) Room no. 317 2nd floor of Hospital Building(Kayachikitsa Deptt.) of Rajiv Gandhi Govt. Ayu. Post Graduate College and Hospital
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
8278751164 |
| Fax |
|
| Email |
anuverma99991@gmail.com |
|
|
Source of Monetary or Material Support
|
| Baijnath Pharmacy Paprola Distt. Kangra HP Self Charak Pharmacy RGGPG Ayurvedic College and Hospital |
|
|
Primary Sponsor
|
| Name |
Principal |
| Address |
RGGPG Ayurvedic College and Hospital, Paprola Kangra HP 176115 |
| 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 Vijay Chaudhary |
Rajiv Gandhi Government Post Graduate Ayurvedic College & Hospital Paprola Distt. Kangra (HP) |
Rajiv Gandhi Government Post Graduate Ayurvedic College & Hospital Paprola Distt Kangra (HP) OPD No 207 and 220 and IPD No 317 of Hospital building in Kayachikitsa Department Kangra Himachal Pradesh
Kangra
HIMACHAL PRADESH |
9418130228
drvijaychaudhary@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committe |
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: Vatrakta, (2) ICD-10 Condition:E00-E89||Endocrine, nutritional and metabolic diseases. Ayurveda Condition: Vatrakta, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Allopurinol | Allopurinol 100mg twice a day for 6 weeks | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shampakadi Kwatha, Reference: Bhaijyaratnavalli Vatraktrogadhikar 27/9, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 42 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients of either gender in the age group between 20-70 years.
2) Patients having serum uric acid level level more than 7mg/dl (male) and more than 6mg/dl (female) with or without any associated features of joint inflammation. |
|
| ExclusionCriteria |
| Details |
1) Patient not willing for the trial.
2) Patient below age of 20 years and above 70 years of age.
3) Patient suffering from any other form of arthritis like osteoarthritis, Tubercular arthritis, Rheumatoid etc.
4) Patient suffering from chronic renal, respiratory, cardiac and hepatic disorders.
5)Patient having malignant disorder.
6) Patients who has completed participation in any other clinical trial during the past 3 months.
7) Any condition which the investigator thinks may comprise with the safety of the subject.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the clinical efficacy of Shampakadi Kwatha in the management of Vatarakta w.s.r. to Hyperuricemia.
Relief in symptoms of Vatrkata after intervention of Shampakadi kwatha
Sandhishoola-joint pain
Sandhishotha-Sweling of the joint
Raga/Redness
Twakavaivarnya/discoloration of skin
Sparasashyata/tenderness
Vidaha- Burning sensation
|
Duration of trial : 6 weeks
Follow up : After every 2 weeks till the completion of trial
Dosage : Shampakadi kwatha – 50 ml Twice a day
Route of administration : Oral
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the clinical safety and adverse effects of Shampakadi Kwath. Improving quality of life |
At the 4weeks, 6 weeks and remain connected with telephonically to know the A.D.Rs if there is any after completion of trial |
|
|
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 4 |
|
Date of First Enrollment (India)
|
25/01/2023 |
| 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="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
I would like to publish my trial as soon as possible . Patients will be selected from OPD/IPD of RGGPG Ayurvedic College and Hospital Paprola. A sample of 30 patients will be registered . Patients will be divided into three groups. Patients will be assessed to evaluate the effect of Shampakadi Kwatha in the management of Vatrakta w.s.r. to Hyperuricemia. |