| CTRI Number |
CTRI/2024/11/076555 [Registered on: 11/11/2024] Trial Registered Prospectively |
| Last Modified On: |
08/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comparative Pharmaceutical -Clinical Study Of Amritadi Ghrita Prepared By Two Different Media and Its Effect on Gout |
|
Scientific Title of Study
|
A Comparative Pharmaceutical Study Of Amritadi Ghrita Prepared by Desi Cow Milk and Jersey Cow Milk and Its Effect on Vatarakta With Special Reference To Gout |
| 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 PURAN UPADHYAY |
| Designation |
M D Scholar Rasa Shastra And Bhaishajya Kalpana |
| Affiliation |
Government P.G Ayurvedic College And Hospital |
| Address |
Department of Rasa and Bhaishjya Kalpana, Government P.G Ayurvedic College And Hospital, Varanasi
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
9369490705 |
| Fax |
|
| Email |
vaidyapuranupadhyay@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ANKIT KUMAR GUPTA |
| Designation |
READER |
| Affiliation |
Government P.G Ayurvedic College And Hospital |
| Address |
Department of Rasa shastra and Bhaishjya kalpana, Government P.G Ayurvedic College And Hospital Varanasi
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
9532016160 |
| Fax |
|
| Email |
drankitg01@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR AJAY KUMAR |
| Designation |
LECTURER |
| Affiliation |
Government P.G Ayurvedic College And Hospital |
| Address |
Department of Swasthvritta, Government P.G Ayurvedic College And Hospital, Varanasi
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
9616870871 |
| Fax |
|
| Email |
drajay2000@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government P.G Ayurvedic College And Hospital, Chaukaghat,Varanasi,Uttar pradesh,221002, India |
|
|
Primary Sponsor
|
| Name |
GOVERNMENT PG AYURVEDIC COLLEGE AND HOSPITAL |
| Address |
Government P.G Ayurvedic College And Hospital Chaukaghat Varanasi Uttar pradesh 221002 India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 PURAN UPADHYAY |
GOVERNMENT P.G. AYURVEDIC COLLEGE AND HOSPITAL |
Department of kaya chikitsa, Opd No 8 & 10
Department of Rasa Shastra and Bhaishjya Kalpana,Opd No 05
Varanasi
UTTAR PRADESH |
9369490705
vaidyapuranupadhyay@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC,Government P.G. Ayurvedic College and Hospital ,Varanasi U.P, Mahayogi Guru Gorakhnath Ayush University ,Gorakhpur,U P |
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 | Intervention Arm | Drug | Classical | | (1) Medicine Name: AMRITADI GHRITA, Reference: SHARANGA DHAR SAMHITA, Route: Oral, Dosage Form: Ghrita, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: LUKE WARM WATER), Additional Information: AMRITADI GHRITA PREPARED BY DESI COW MILK | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: AMRITADI GHRITA, Reference: SHARANGA DHAR SAMHITA, Route: Oral, Dosage Form: Ghrita, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: LUKE WARM WATER), Additional Information: AMRITADI GHRITA PREPARED BY JERSEY COW MILK |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of either gender in the age group between 20-60 years.
2. Patients who fulfilled the diagnostic criteria.
3. Patients who have serum uric acid level more than 7mg/d in males and more than
6mg/dl in females with or without any associate feature like joint pain and inflammation.
4. Disease presenting with classical clinical feature of Vatarakta like, Sandhi shool (Joint pain), Sandhi shotha (Swelling of joint), Sparsha asahatvam (Tenderness), Raga (Redness), Twak vaivarnya (Discolouration of skin) and Vidaha(Burning sensation).
5. Patients who are willing to participate in trial. |
|
| ExclusionCriteria |
| Details |
1. Patients who are not willing to participate in trial.
2. Patients below the age of 20 years and above 60 years of age.
3. Patient having chronic symptoms of Vatarakta along with other deformities.
4. Patients who are suffering from any other form of arthritis like Osteoarthritis, Tubercular Arthritis, Rheumatoid Arthritis etc.
5. Patients who are suffering from chronic renal, respiratory, cardiac or hepatic disorder.
Patients who have any malignancy.
6. Patients who are pregnant and lactating mother |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in reduction of increased Uric acid and Symptomatic relief |
Within 14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Normal level of Uric acid & complete symptomatic relief |
With in 30 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 3 |
|
Date of First Enrollment (India)
|
03/12/2024 |
| 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="2"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This study is interventional study trial, comparing the efficacy of AMRITADI GHRITA in gout which is prepared by two different media. Patient will be randomly selected from OPD of department of Rasa shastra and Bhaishajya Kalpana and Kayachikitsa, at government P.G ayurvedic college and hospital, Varanasi. 60 patients will be studied under 2 group; having 30 patients in each group.
Group -A - 30 patients will be treated by AMRITADI GHRITA prepared by Desi cow milk. Group -B - 30 patients will be treated by AMRITADI GHRITA prepared by Jersey cow milk. |