| CTRI Number |
CTRI/2024/10/075813 [Registered on: 24/10/2024] Trial Registered Prospectively |
| Last Modified On: |
22/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative clinical study of Aragwadha churna and Guduchi churna in Vatarakta |
|
Scientific Title of Study
|
Effect of Aragwadha churna as compared to Guduchi churna in management of Vatarakta (Gout):A Randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
VDSonam Gajendra Dhiwar |
| Designation |
PG Scholar |
| Affiliation |
Shri Ayurved Mahavidyalaya, Nagpur |
| Address |
Kayachikitsa Department,Pakwasa Samnavaya Rugnalaya,Shri Ayurved Mahavidyalaya,Hanuman Nagar,Nagpur
Nagpur
MAHARASHTRA
440024
India |
| Phone |
9637639806 |
| Fax |
|
| Email |
dhiwarsonam97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vd Mrityunjay Sharma |
| Designation |
Asso.Professor |
| Affiliation |
Shri Ayurved Mahavidyalaya,Nagpur |
| Address |
Kayachikitsa Department, Pakwasa Samnavaya Rugnalaya, Shri Ayurved Mahavidyalaya, Nagpur
Nagpur
MAHARASHTRA
440024
India |
| Phone |
9373103182 |
| Fax |
|
| Email |
mrityunjaysharma22@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vd Mrityunjay Sharma |
| Designation |
Asso.Professor |
| Affiliation |
Shri Ayurved Mahavidyalaya,Nagpur |
| Address |
Kayachikitsa Department, Pakwasa Samnavaya Rugnalaya, Shri Ayurved Mahavidyalaya Nagpur
Nagpur
MAHARASHTRA
440024
India |
| Phone |
9373103182 |
| Fax |
|
| Email |
mrityunjaysharma22@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Ayurved Mahavidyalaya, Nagpur |
|
|
Primary Sponsor
|
| Name |
VdSonam Gajendra Dhiwar |
| Address |
Kayachikitsa Department, Pakwasa Samnavaya Rugnalaya,Shri Ayurved Mahavidyalaya,Nagpur
|
| 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 |
| VdSonam Gajendra Dhiwar |
Shri Ayurved Mahavidyalaya, Nagpur |
Kayachikitsa Department, Pakwasa Samnavaya Rugnalaya,Shri Ayurved Mahavidyalaya,Nagpur
Nagpur
MAHARASHTRA |
9637639806
dhiwarsonam97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee of Shri Ayurved Mahavidyalaya, Nagpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M100||Idiopathic gout. Ayurveda Condition: VATARAKTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Aragwadha Churna, Reference: Charak samhita Kalpasthana, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Guduchi Churna , Reference: Charak samhita Chikitsasthana , Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient with sign and symptoms of Vatarakta as mentioned in Samhitas.
Patient age group between 30-60yrs.
Patients selected irrespective of age, Sex, socio economic status.
Patient with hyperuricemia 7-10 mg/dl.
Newly diagnosed patients. |
|
| ExclusionCriteria |
| Details |
Pregnant women and lactating mothers.
Patients with sign and symptoms of Amavata and
Sandhigatavata.
Patient having sign and symptoms of vatarakta more than 1 year.(chronic gout).
Patient with uric acid level above 10 mg/ |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the effect of Aragwadha churna and Guduchi
churna in the management of vatarakta (gout)to be assessed
by relief of symptoms
To compare the effect of Aragwadha churna and Guduchi
churna in the management of vatrakta(gout) to be assessed
by sr.uric acid level |
Follow up will be taken every 7th day for 28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the effect of Aragwadha churna and Guduchi
churna in the management of vatrakta(gout) to be assessed
by sr.uric acid level |
At the end of 28 days |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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)
|
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
|
In the present study, total 68 participants will be taken for trial dividing them in 2 equal groups. Grp-A will receive the trial drug ’Aragwadha churna’ and Grp-B will receive the control drug ’Guduchi churna’ twice a day for 28 days. Follow up will be taken every 7th day for 28 days . Result will be concluded based on assessment criteria. |