| CTRI Number |
CTRI/2020/07/026386 [Registered on: 06/07/2020] Trial Registered Prospectively |
| Last Modified On: |
02/09/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of selected Ayurvedic Formulation for the treatment of Urinary Track Infection. |
|
Scientific Title of Study
|
A Comparative Clinical Study To Evaluate The Effect Of Dhatryadi Kwatha And Dhatryadi Kwatha With Yavakshara In The Management Of Urinary Tract Infection W.S.R. To Mutrakrichhra |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrAnjana Mishra |
| Designation |
M.D.(Ay) Kayachiktsa |
| Affiliation |
Rajiv Gandhi Govt.Post Graduate Ayurvedic College and Hospital,Paprola , (HP) |
| Address |
V.P.O.Kharanal, Teh.Baijnath, Distt.Kangra,(H.P.)
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
94183-12324 |
| Fax |
|
| Email |
dranjana269@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrAnjana Mishra |
| Designation |
M.D.(Ay) Kayachiktsa |
| Affiliation |
Rajiv Gandhi Govt.Post Graduate Ayurvedic College and Hospital,Paprola , (HP) |
| Address |
V.P.O.Kharanal, Teh.Baijnath, Distt.Kangra,(H.P.)
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
94183-12324 |
| Fax |
|
| Email |
dranjana269@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vivek Lohan |
| Designation |
M.D.(Ay) Scholar |
| Affiliation |
Rajiv Gandhi Govt.Post Graduate Ayurvedic College and Hospital,Paprola , (HP) |
| Address |
RGGPG Ayurvedic College, Paprola, Distt.Kangra,(H.P.)
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
8684928864 |
| Fax |
|
| Email |
viveklohan4840@gmail.com |
|
|
Source of Monetary or Material Support
|
| Baijnath Pharmacy, Paprola District Kangra,Himachal Pradesh
Charak Pharmacy, RGGPG Ayurvedic college and Hospital,Paprola District Kangra ,HP
Research Institute in I.S.M. Joginder Nagar,Himachal Pradesh |
|
|
Primary Sponsor
|
| Name |
Principal RGGPG Ayu College Paprola |
| Address |
RGGPG Ayurvedic College and Hospital Paprola |
| 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 Anjana Mishra |
Rajiv Gandhi Ayurvedic College and Hospital |
Room No. 315, Department of Kayachikitsa, RGGPG Ayurvedic College and Hospital Paprola (H.P) Kangra HIMACHAL PRADESH
Kangra
HIMACHAL PRADESH |
9418312324
dranjana269@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC(human)RGGPG Ayurvedic College Paprola |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N390||Urinary tract infection, site notspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dhatryadi kwatha |
40 ml twice a day for 4 weeka duration(Bha.Ratna.34/23) |
| Comparator Agent |
Dhatryadi Kwatha and Yavakshara |
40ml twice a day for 4 weeks duration (Bha.Ratna.34/23)
1 gm twice a day for 4 weeks duration (Bha.Ratna.34/15 |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients above the age of 20-70 years.
Patients willing for the trial.
Patients who present with sign and symptoms of Mutrakrichhra as mentioned in classical texts |
|
| ExclusionCriteria |
| Details |
Patients below the age of 20 years and above the age of 70 years.
Patients not willing for trial.
Case of associated obstructed uropathy , malignancy and tuberculosis of urinary tract.
The patients who have serious organic and metabolic ailments |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Fulfillment of objective and subjective criteria |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| General well being |
4 weeeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
10/07/2020 |
| Date of Study Completion (India) |
09/03/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
I would like to publish my research trial after completion of the trail as soon as possible . Patients will be selected from campus faculty /OPD of RGGPG Ayurvedic college and Hospital, Paprola.Two groups of 30 Patients will be registered and then assessed on the basis of subjective and objective parameters. |