| CTRI Number |
CTRI/2024/10/075108 [Registered on: 10/10/2024] Trial Registered Prospectively |
| Last Modified On: |
21/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Reducing Urinary tract infection Mutrakrichhra symptoms with Shatavaryadi ghrita |
Scientific Title of Study
Modification(s)
|
Clinical evaluation of Shatavaryadi Ghrita In Paittik Mutrakrichhra |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Alok Kumar Sharma |
| Designation |
Pg Scholar |
| Affiliation |
Quadra Institute of Ayurveda and Hospital |
| Address |
Opd No 2 Department Of Kayachikitsa Quadra Institute Of Ayurveda And Hospital Nh58 Roorkee Haridwar Road Near Montfort School Roorkee 247667
Hardwar
UTTARANCHAL
247667
India |
| Phone |
09451468493 |
| Fax |
|
| Email |
aloksharmapyp@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhishek Bhusan Sharma |
| Designation |
Professor |
| Affiliation |
Quadra Institute of Ayurveda and Hospital |
| Address |
Opd No 2 Department Of Kayachikitsa Quadra Institute Of Ayurveda And Hospital Nh58 Roorkee Haridwar Road Near Montfort School Roorkee 247667
Opd No 2 Department Of Kayachikitsa Quadra Institute Of Ayurveda And Hospital Nh58 Roorkee Haridwar Road Near Montfort School Roorkee 247667
Hardwar
UTTARANCHAL
247667
India |
| Phone |
9458636020 |
| Fax |
|
| Email |
ayu.abhishek@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ALOK KUMAR SHARMA |
| Designation |
Pg Scholar |
| Affiliation |
Quadra Institute of Ayurveda and Hospital |
| Address |
Opd No 2 Department Of Kayachikitsa Quadra Institute Of Ayurveda And Hospital Nh58 Roorkee Haridwar Road Near Montfort School Roorkee 247667
Hardwar
UTTARANCHAL
247667
India |
| Phone |
09451468493 |
| Fax |
|
| Email |
aloksharmapyp@gmail.com |
|
|
Source of Monetary or Material Support
|
| Opd No 2 Department Of Kayachikitsa Quadra Institute Of Ayurveda And Hospital Nh58 Roorkee Haridwar Road Near Montfort School Roorkee 247667 |
|
|
Primary Sponsor
|
| Name |
ALOK KUMAR SHARMA |
| Address |
Opd No 2 Department Of Kayachikitsa Quadra Institute Of Ayurveda And Hospital Nh58 Roorkee Haridwar Road Near Montfort School Roorkee 247667 |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Alok Kumar Sharma |
Quadra Institute of Ayurveda And Hospital Roorkee |
Opd No 2 Department Of Kayachikitsa Quadra Institute Of Ayurveda And Hospital Nh58 Roorkee Haridwar Road Near Montfort School Roorkee 247667
Hardwar
UTTARANCHAL |
9451468493
aloksharmapyp@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE QUADRA INSTITUTE OF AYURVEDA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N399||Disorder of urinary system, unspecified. Ayurveda Condition: MUTRAKRUCCRAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: SHATAVARYADI GHRITA, Reference: CHAKRADUTTA OF SHRI CHAKRAPANIDATTA MUTRAKRICHHRA CHIKITSA ADHAYA 32 SALOK NO 28 , Route: Oral, Dosage Form: Ghrita, Dose: 6(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -LUKEWARM WATER), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Individuals between the age group of 15-50 years will be selected.
2. Individuals irrespective of gender, religion, race, occupation will be selected for the study.
3. Individuals with classical signs and symptoms of Paittik Mutrakrichhra will be selected
4. Abnormally increased pus cell and leucocytes increases in urine sample.
5. New and previously treated cases would be taken for the study. |
|
| ExclusionCriteria |
| Details |
1. Individuals aged group of below 15 and above 50 years will be excluded.
2. Pregnant or lactating women will be excluded.
3. Individuals with a history of renal diseases, diabetes mellitus, diabetes insipidus,
pyelonephritis ,uncontrolled hypertension, surgical history (phimosis) ,severe
complication of the cardiovascular or hematopoietic systems , mental diseases and any
other major illness will excluded.
4. Individuals with a history of complicated urinary tract infections. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To help relief in symptoms of paittik mutrakrichhra
|
First follow up-after 7 days of first trial
Second follow up-7 days after first follow up
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Provide a alternative & safe treatment for
pittaja mutrakricchra |
18 months |
|
|
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 2 |
|
Date of First Enrollment (India)
|
24/10/2024 |
| 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
|
This Is An Open Label Clinical
Study To Evaluate The Effect Of Shatavaryadi Ghrita In The Management Of
Mutrakrichhra (Urinary Tract Infections) It will be a clinical study of 30 patients suffering from urinary tract infections. patient will be randomly selected irrespective of their gender,race,religion,occupation-patient with classical features of Mutrakrichhra attending the OPD and IPD of Kayachikitsa department of Quadra institute of Ayurveda Roorkee will be selected for this clinical study. The patients between the age group of 15 to 50 years of age.The assessment of the trial will be done on the basis of subjective and objective parameters.The period of study is 18 months and duration of study is 15 days.Data depending upon above subjective and objective criteria and other variables will be collected and analyzed statistically |