| CTRI Number |
CTRI/2022/09/045764 [Registered on: 22/09/2022] Trial Registered Prospectively |
| Last Modified On: |
10/09/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) |
| Study Design |
Other |
|
Public Title of Study
|
Effect of Kwatha and Churna in the management of Pittaj Mutrakrichra with special reference to urinary Tract Infection |
|
Scientific Title of Study
|
A comparative clinical study to evaluate the effect of Haritakyadi Kwatha and Eladi Churna in the management of Pittaj Mutrakrichra with special reference to 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 |
Dr Sunil Thakur |
| Designation |
MD (Ayu) Reader Kayachikitsa department |
| Affiliation |
Rajiv Gandhi Govt Post Graduate Ayurvedic College Paprola |
| Address |
Department of kayachikitsa room no 220 Rajiv Gandhi Govt Post Graduate Ayurvedic College
Rajiv Gandhi Govt Post Graduate Ayurvedic College
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9816195001 |
| Fax |
|
| Email |
dr.skumarthakur@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunil Thakur |
| Designation |
MD (Ayu) Reader Kayachikitsa department |
| Affiliation |
Rajiv Gandhi Govt Post Graduate Ayurvedic College Paprola |
| Address |
Department of kayachikitsa room no 220 Rajiv Gandhi Govt Post Graduate Ayurvedic College
Rajiv Gandhi Govt Post Graduate Ayurvedic College
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9816195001 |
| Fax |
|
| Email |
dr.skumarthakur@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Swati |
| Designation |
Pg Scholar |
| Affiliation |
Rajiv Gandhi Govt Post Graduate Ayurvedic College Paprola |
| Address |
Kayachikitsa department Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital paprola
Rajiv Gandhi Govt Post Graduate Ayurvedic College
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
7018909839 |
| Fax |
|
| Email |
thakurvedica93@gmail.com |
|
|
Source of Monetary or Material Support
|
| Baijnath pharmacy Paprola District Kangra Himachal Pradesh |
|
|
Primary Sponsor
|
| Name |
Rajiv Gandhi Govt Post Graduate Ayurvedic College and HospitalPaprola |
| Address |
Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital Paprola District Kangra Pin code 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 Sunil Thakur |
Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital Paprola |
kayachikitsa department room no. 220 Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital Paprola Distt kangra pin code 176115
Kangra
HIMACHAL PRADESH |
9816195001
dr.skumarthakur@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEChuman |
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: PITTAJAMUTRAKRUCCRAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Eladi churna, Reference: Chakardutt chapter no 22, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 4 Weeks, anupAna/sahapAna: Yes(details: -Tandulodak and guda), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Haritakyadi Kwatha, Reference: chakradutt chapter 6, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 4 Weeks, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients above the age of 20 -70 yrs.
2 Patients who present with any of the following sign symptoms
Sarakta Mutrata - Haematuria
Saruja Mutrata - Painful micturition
Sadaha Mutrata - Burning micturition
Krichra Mutrata - Difficulty during micturition
Muhur Muhur Mutrata - Increased frequency of micturition
Pita Mutrata - Turbidity of urine
3 Patients willing for trial and the patients who had no serious organic or metabolic ailments. |
|
| ExclusionCriteria |
| Details |
1Patients Below the age of 20yrs and above the age of 70yrs
2 Patients not willing for trial
3 Patient with chronic renal Failure and diabetes mellitus will be excluded
4 Case of associated obstructed uropathy and suffering from chronic illness
5 Pregnant & lactating women |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Relief in symptoms of Pittaj Mutrakrichra after intervention of Haritakyadi kwatha and Eladi churna
Sarakta Mutrata - Haematuria
Saruja Mutrata - Painful micturition
Sadaha Mutrata - Burning micturition
Krichra Mutrata - Difficulty during micturition
Muhur Muhur Mutrata - Increased frequency of micturition
-
Pita Mutrata - Turbidity of urine |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improving quality of life |
4 weeks |
|
|
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)
|
25/09/2022 |
| 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="0"
Days="28" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
patients will be selected from faculty/OPD of RGGPG Ayurvedic College and Hospital, Paprola. Two groups of 15 patients will be selected on the basis of inclusion and exclusion criteria. Interventional drug will be given to both groups of patient to know the effect of kwatha and churna. |