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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator Arm (Non Ayurveda)-Nitrofurantoinwill be given 500mg OD, orally for 14days
2Intervention ArmDrugClassical(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: -
3Comparator Arm (Non Ayurveda)-Antibiotics with GokshuraThird 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.
 
 
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.
 
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