| CTRI Number |
CTRI/2020/08/027276 [Registered on: 20/08/2020] Trial Registered Prospectively |
| Last Modified On: |
17/08/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Clinical and Experimental] |
| Study Design |
Other |
|
Public Title of Study
|
Antimicrobial Effect of Trikantakadi Kwath |
|
Scientific Title of Study
|
An Experimental and Clinical Study on the Effectiveness of Trikantakadi Kwath on Pittaja Mutrakrichha w.s.r. to U.T.I. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajesh Kumar Manglesh |
| Designation |
Reader, Rog Nidana Evam Vikriti vigyana |
| Affiliation |
Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital, Paprola, District- Kangra |
| Address |
Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital, Paprola, District- Kangra
VPO- Sehal, Teh- Baijnath, District- Kangra (HP)
176125
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9816324204 |
| Fax |
|
| Email |
drrkmanglesh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh Kumar Manglesh |
| Designation |
Reader, Rog Nidana Evam Vikriti vigyana |
| Affiliation |
Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital, Paprola, District- Kangra |
| Address |
Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital, Paprola, District- Kangra
VPO- Sehal, Teh- Baijnath, District- Kangra (HP)
176125
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9816324204 |
| Fax |
|
| Email |
drrkmanglesh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kristina Singtan |
| Designation |
Student, Department of Rog Nidana Evam Vikriti Vigyana, RGG PG Ayu. College and Hospital, Paprola |
| Affiliation |
Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital, Paprola, District- Kangra |
| Address |
Room No: 208,Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital, Paprola, District- Kangra
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
6230379209 |
| Fax |
|
| Email |
singtankristina@gmail.com |
|
|
Source of Monetary or Material Support
|
| Charak Pharmacy, RGGPG Ayurvedic College and Hospital,Paprola, Kangra(HP)
Research Institute in I.S.M. Joindernagar (HP)
Chunni Lal Kalyan Bux 363 Tripoliya Bazar, Jaipur (Raj.)
K.L. Mehta & Co., Bazar Wahian Wala, Majith Mandi, Amritsar (Punjab) |
|
|
Primary Sponsor
|
| Name |
RGGPG Principal RGG PG Ayu Ayurvedic College and Hospital Paprola |
| Address |
Paprola, District- Kangra, Himachal Pradesh, 176115 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| HOD |
Department Of Rog Nidana Evam Vikriti Vigyana, RGGPG Ayurvedic College and Hospital, Paprola, District- Kangra, Himachal Pradesh |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Prasenjit Dhar |
Dr GC Negi College of Veterinary and Animal Sciences |
Department of Microbiology, NH154, Holta, Palampur
Kangra
HIMACHAL PRADESH |
8628956097
thakurprasen727779@gmail.com |
| Dr Rajesh Kumar Manglesh |
Rajiv Gandhi Government Post Graduate Ayurvedic College |
Room No- 208, Department of Rog Nidana Evam Vikriti Vigyana,Paprola
Kangra
HIMACHAL PRADESH |
9816324204
drrkmanglesh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (Human) RGG PG Ayu. College and Hospital, 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 |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Trikantakadi Kwath |
50 ml of kwath is mixed with 12 gram of honey and given twice a day for 14 days.
Reference: Chakradatta |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient willing to undergo trial.
2.All infections of the urinary tract in men, women, and also in pregnant women without any bar of sex, race, religion and socio-economic status.
3.Patients presenting with signs and symptoms of Pittaja Mutrakrichha and urine sample with Pus cell, red blood cell, epithelial cells and micro organism under microscopic examination.
4.All the patients will be examined and assessed by detailed case history, through clinical examination and relevant laboratory investigations to diagnose the disease.
5.Immuno-suppressed patients, urological or renal disease, and a status after laying a urine catheter.
|
|
| ExclusionCriteria |
| Details |
1.Patients who are not willing to participate in the trial.
2.Urine sample not having presence of pus cells.
3.Patients having other organic diseases with urinary tract infections.
4.Patients below 16 years and above 70 years of age.
5.Menstruating women.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Fulfillment of objective and subjective criteria |
14 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| General feeling of Well- being |
21 days |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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
|
N/A |
|
Date of First Enrollment (India)
|
20/08/2020 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
I would like to publish my research trial after completion of the trial as soon as possible. Patients will be selected from OPD and IPD of RGGPG Ayurvedic College and Hospital, Paprola, District- Kangra (HP). One group of 15 number of patients will be registered and then assessed on the basis of Subjective and Objective criteria. Antimicrobial activity of Trikantakadi Kwath and its ingredient individually will also be studied in the characterized strains of bacteria causing UTI making discs. |