| CTRI Number |
CTRI/2021/10/037660 [Registered on: 28/10/2021] Trial Registered Prospectively |
| Last Modified On: |
24/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the effect of Guda Amalak Yog in management of pittaj mutrakruchchra |
|
Scientific Title of Study
|
OPEN RANDOMIZED CONTROLLED CLINICAL TRIAL OF GUDA AMALAK YOGA IN PITTAJ MUTRAKRUCHCHRA( URINARY TRACT INFECTION ) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sayyad Mubin Masim |
| Designation |
PG Scholar Kayachikitsa |
| Affiliation |
Hon. shri. Annasaheb Dange Ayurved Medical college , Ashta |
| Address |
Hon. Shri. Annasaheb Dange Ayurved Medical college,Kayachikitsa opd no-1 Ashta Tal- Walwa Dist - Sangli
Hon. Shri. Annasaheb Dange Ayurved Medical college,Kayachikitsa opd no-1 Ashta Tal- Walwa Dist - Sangli
Sangli
MAHARASHTRA
416 301
India |
| Phone |
9545437868 |
| Fax |
|
| Email |
mubinsayyad11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Smita Lokhande |
| Designation |
Assistant Proffesor |
| Affiliation |
Hon. shri. Annasaheb Dange Ayurved Medical college , Ashta |
| Address |
Hon. Shri. Annasaheb Dange Ayurved Medical college,Kayachikitsa opd no-1 Ashta Tal- Walwa Dist - Sangli
Hon. Shri. Annasaheb Dange Ayurved Medical college,Kayachikitsa opd no-1 Ashta Tal- Walwa Dist - Sangli
Sangli
MAHARASHTRA
416 301
India |
| Phone |
8149556591 |
| Fax |
|
| Email |
yoshitpriya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Smita Lokhande |
| Designation |
Assistant Proffesor |
| Affiliation |
Hon. shri. Annasaheb Dange Ayurved Medical college , Ashta |
| Address |
Hon. Shri. Annasaheb Dange Ayurved Medical college, Kayachikitsa opd no- 1 Ashta Tal- Walwa Dist - Sangli
Hon. Shri. Annasaheb Dange Ayurved Medical college, Kayachikitsa opd no -1 Ashta Tal- Walwa Dist - Sangli
Sangli
MAHARASHTRA
416 301
India |
| Phone |
8149556591 |
| Fax |
|
| Email |
yoshitpriya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hon. Shri. Annasaheb Dange Ayurved Medical college , Ashta |
|
|
Primary Sponsor
|
| Name |
Hon Shri Annasaheb Dange Ayurved Medical College Ashta |
| Address |
Ashta Tal- Walwa Dist- Sangli Pin code- 416 301 |
| Type of Sponsor |
Private 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 |
| Sayyad Mubin Masim |
Dhanvantari Hospital , Kayachikitsa opd no- 1 Ashta |
Ashta Tal- Walwa Dist - Sangli
Sangli
MAHARASHTRA |
9545437868
mubinsayyad11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N390||Urinary tract infection, site notspecified. Ayurveda Condition: MUTRAKRUCCRAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: GUDA AMALAK YOGA , Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: -Sheeta jala ), Additional Information: Drug reference chakradatta 32/8 |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient having signs and symptoms of pittaj mutrakruchchra will be randomly selected .
2. Patients irrespective of Gender, Economic Class, Caste, Race , Religion.
3. Patients having age between 18 to 60 years .
4. Urine pus cell upto 10 hpf.
5. RBCs in urine upto 10 hpf. |
|
| ExclusionCriteria |
| Details |
1. Patients having malignancy, benign prostrate hyperplasia, pyelonephritis, diabetes mellitus and traumatic causes.
2. Urinary tract infection associated with calculi which need surgical intervention.
3. HIV Positive , HbsAg Positive.
4. Neurological diseases causing urinary retention ,presence of foreign bodies such as indwelling catheters other drainage devices.
5. Chronic kidney disease, Renal failure, Renal transplant patient .
6. Patient who are on antiplatelet medication.
7. Pregnancy and lactating mother. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Guda Amalak Yog is effective in pittaj mutrakruchchra |
14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Shatavari Churna is effective in pittaj mutrakruchchra |
14 days |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
Final Enrollment numbers achieved (Total)= "68"
Final Enrollment numbers achieved (India)="68" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
15/11/2021 |
| Date of Study Completion (India) |
24/07/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
URINARY TRACT INFECTION - AYURVEDIC AND MODERN PERSPECTIVE |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Open Randomized controlled clinical trial of Guda Amalak Yog in pittaj mutrakruchchra . In this study i will take 68 patients from india . |