| CTRI Number |
CTRI/2021/06/034369 [Registered on: 24/06/2021] Trial Registered Prospectively |
| Last Modified On: |
22/01/2022 |
| 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
|
Intervention of Haritakyadi kwath in the management of urinary tract infection |
|
Scientific Title of Study
|
An experimental and clinical study to evaluate the effect of Haritkyadi kwath in pittaja muttrakricha(UTI in pregnancy)w.s.r to nidan and deha prakriti |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Akhilesh Kumar Srivastava |
| Designation |
Sr. Lecturer, Roga Nidana Evam Vikriti Vigyana |
| Affiliation |
Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital, Paprola, District- Kangra |
| Address |
Room no. 208, Roga Nidana Evam Vikriti Vigyana,RGG PG Ayurvedic College and Hospital, Paprola, Distt. Kangra (HP) 176115
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418118318 |
| Fax |
|
| Email |
drakhilesh.srivastava@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Akhilesh Kumar Srivastava |
| Designation |
Sr. Lecturer, Roga Nidana Evam Vikriti Vigyana |
| Affiliation |
Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital, Paprola, District- Kangra |
| Address |
Room no. 208, Roga Nidana Evam Vikriti Vigyana,RGG PG Ayurvedic College and Hospital, Paprola, Distt. Kangra (HP) 176115
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418118318 |
| Fax |
|
| Email |
drakhilesh.srivastava@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Akshay Kumar |
| Designation |
MD Scholar, Roga Nidana Evam Vikriti Vigyana |
| Affiliation |
Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital, Paprola, District- Kangra |
| Address |
RGG PG Ayurvedic College and Hospital, Paprola, Distt. Kangra (HP) 176115
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418417010 |
| Fax |
|
| Email |
akshaythebosssarswat@gmail.com |
|
|
Source of Monetary or Material Support
|
| Charak Pharmacy, RGGPG Ayurvedic College and Hospital, Paprola, Kangra (HP), Research Institute in I.S.M Jogindernagar (HP),Shashi Pal Gourav Kumar,Paprola |
|
|
Primary Sponsor
|
| Name |
RGGPG Principal RGG PG Ayu Ayurvedic College and Hospital Paprola |
| Address |
RGGPG Ayurvedic College and Hospital, Paprola, Distt. Kangra (HP) 176115 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| HOD |
Department of Rog Nidana Evam Vikriti Vigyana, Paprola, Distt. Kangra (HP) 176115 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Akhilesh Kumar Srivastava |
RGGPG Ayurvedic College and Hospital, Paprola (HP)- 176115 |
Room no: 208, Department of Roga Nidana Evam Vikriti Vigyana
Kangra
HIMACHAL PRADESH |
9418118318
drakhilesh.srivastava@yahoo.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. Ayurveda Condition: MUTRAKRUCCRAM, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Haritakyadi Kwath |
50 ml of kwath mixed with 12 gm of honey will be given twicw a day for 21 days |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Patient willing to undergo trial, all infection of urinary tract in pregnancy, Patients presenting with sign and symptoms and urine sample with pus cells, epithelial cells and microorganisms under microscopic examination |
|
| ExclusionCriteria |
| Details |
Patients not willing to participate in the trial, urine sample not having pus cells, patients having other organic diseases with UTI |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Fulfilment of subjective criteria and objective criteria
subjective criteria
1 Saruja Mutrata (Painful micturition)
2 Muhur Muhur Mutrata (Increased frequency of urine)
3 Mutrata (Burning micturition)
4 Peeta/Shweta Mutrata (Turbid Urine)
5 Krichra Mutrata (Difficulty in micturition)
6 Sarakta Mutrata (Haematuria)
Objective criteria
1 Pus cells in urine
2 Urine C/S test |
21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| General feeling of wellbeing |
21 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
28/06/2021 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 Hospital. One group of 40 number of patients will be registered and then assed on the basis of subjective and objective criteria. Experimental work will be conducted to study the Antimicrobial activity of Haritakyadi kwath and its ingredients by using different strains of bacteria. |