| CTRI Number |
CTRI/2024/11/076138 [Registered on: 01/11/2024] Trial Registered Prospectively |
| Last Modified On: |
26/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Role of Gokshur in treatment of Urinary Tract Infection in Pregnant females. |
|
Scientific Title of Study
|
A Clinico-microbiological study to isolate and identify Urinary Tract Infection (UTI) causing microbes in pregnancy and effects of Gokshur (Tribulus terrestris). |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Alok Pandey |
| Designation |
Research Scholar |
| Affiliation |
BANARAS HINDU UNIVERSITY |
| Address |
DEPARTMENT OF PRASUTI TANTRA FACULTY OF AYURVEDA IMS B.H.U. VARANASI U.P. 221005
Varanasi UTTAR PRADESH 0548 India |
| Phone |
9795844605 |
| Fax |
|
| Email |
alokimsbhu06@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Alok Pandey |
| Designation |
Research Scholar |
| Affiliation |
BANARAS HINDU UNIVERSITY |
| Address |
DEPARTMENT OF PRASUTI TANTRA FACULTY OF AYURVEDA IMS B.H.U. VARANASI U.P. 221005
Varanasi UTTAR PRADESH 0548 India |
| Phone |
9795844605 |
| Fax |
|
| Email |
alokimsbhu06@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
alok pandey |
| Designation |
research scholar |
| Affiliation |
|
| Address |
DEPARTMENT OF PRASUTI TANTRA FACULTY OF AYURVEDA IMS B.H.U. VARANASI U.P. 221005
Varanasi UTTAR PRADESH 0548 India |
| Phone |
9795844605 |
| Fax |
|
| Email |
alokimsbhu06@gmail.com |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF PRASUTI TANTRA, FACULTY OF AYURVEDA, IMS, B.H.U, VARANASI U.P. |
|
|
Primary Sponsor
|
| Name |
Banaras Hindu University |
| Address |
DEPARTMENT OF PRASUTI TANTRA, FACULTY OF AYURVEDA, IMS, B.H.U, VARANASI, U.P-221005 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Anuradha Roy |
Institute of Medical Sciences, Banaras Hindu University |
SIR SUNDERLAL HOSPIAL, IMS, B.H.U, VARANASI U.P. 221055 Varanasi UTTAR PRADESH |
9956630433
dranuradha369@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BANARAS HINDU UNIVERSITY |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N018||Rapidly progressive nephritic syndrome with other morphologic changes. Ayurveda Condition: MUTRA-VEGARODHAH/MUTRAGRAHA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Nitrofurantoin | will be given 500mg OD, orally for 14days | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Gokshur, Reference: Charaka Sanhita, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: od, Bhaishajya Kal: Sabhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: With Water), Additional Information: - | | 3 | Comparator Arm (Non Ayurveda) | | - | Antibiotics with Gokshura | Third arm will be given both the susceptible antibiotics in combination with Gokshur for 14days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant women suspected with UTI, patients having presence of high number of RBCs, pus cells, epithelial cells, bacteria; and patient having bacterial growth on urine culture. |
|
| ExclusionCriteria |
| Details |
Age below 18 years or above 45 years; Patients on antibiotic therapy; Diabetic patients; Viral marker reactive patients; and those not consenting for the study.
|
|
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Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary Outcome:
Complete Response: Disc size less than 7mm.
Partial Response: Disc size 7 to 14mm.
No Response: Disc size greater than 14mm. |
At the end of 14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary Outcome:
Complete Response: No clinical signs or symptoms
No Response: Persistent/ Recurrence clinical signs & symptoms |
At the end of 1month |
|
|
Target Sample Size
|
Total Sample Size="135" Sample Size from India="135"
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 3 |
|
Date of First Enrollment (India)
|
09/12/2024 |
| 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="2" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Urinary Tract Infection (UTI) is a common complication during pregnancy and can lead to serious maternal and fetal outcomes. UTI can be asymptomatic, with bacteria present in urine without symptoms, or symptomatic, characterized by symptoms like dysuria, frequent urination, suprapubic pain, and fever. Infections of the upper urinary tract, such as pyelonephritis, can result in more severe complications like preterm labor, anemia, and even maternal death. Risk factors for UTI in pregnancy include physiological changes, a history of UTI, advanced maternal age, and poor hygiene. Common pathogens responsible for UTI include *Escherichia coli*, *Klebsiella*, *Proteus mirabilis*, and *Enterococcus*. Prevalence rates of UTI during pregnancy range from 4-25%, and treatment typically involves a short course of antibiotics. However, antibiotics such as Nitrofurantoin and Trimethoprim-Sulfamethoxazole are avoided in the first trimester due to potential fetal risks. Additionally, the overuse of antibiotics has led to drug resistance, posing a challenge in treating UTI.
To address these challenges, alternative treatments like the use of Gokshura (*Tribulus terrestris*), a traditional Ayurvedic herb with antimicrobial and diuretic properties, are being explored. Gokshura is known for balancing doshas and aiding in the treatment of UTI symptoms without the side effects associated with antibiotics. The study aims to evaluate the efficacy of Gokshura in treating UTI during pregnancy, comparing its effects alone and in combination with conventional antibiotics. Additionally, it seeks to isolate and identify the bacteria responsible for UTI in pregnant women and determine the minimum inhibitory concentration (MIC) of Gokshura and antibiotics against these pathogens. |