| CTRI Number |
CTRI/2025/12/098866 [Registered on: 11/12/2025] Trial Registered Prospectively |
| Last Modified On: |
10/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Clinical study to evaluate the efficacy of Shatavari Kwatha along with its Antimicrobial effect in Garbhini Mutrakrichhra w.s.r. to UTI in Pregnancy |
|
Scientific Title of Study
|
A Clinical study to evaluate the efficacy of Shatavari Kwatha along with its Antimicrobial effect in Garbhini Mutrakrichhra w.s.r. to UTI in Pregnancy |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr.Seema Shukla |
| Designation |
Retired Professor |
| Affiliation |
Rajiv Gandhi Government Post Graduate Ayurvedic College and hospital PaprolaDistt kangra HP 176115 |
| Address |
Re-employed At
Awasthi Ayurvedic Medical College And Hospital Nalagarh Dist .Solan 174101
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418008833 |
| Fax |
|
| Email |
drseemanil@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Soni Kapil |
| Designation |
HOD Professor, Prasuti Tantra evum Stree Roga |
| Affiliation |
Rajiv Gandhi Government Post Graduate Ayurvedic College and hospital PaprolaDistt kangra HP 176115 |
| Address |
P.G. dept of PTSR, Room No 203,Rajiv Gandhi Government Post Graduate Ayurvedic College and hospital
Paprola Distt kangra Baijnath Himachal Pradesh 176115 India
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418499799 |
| Fax |
|
| Email |
skbhardwaj73@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nikita Nagre |
| Designation |
PG Scholar, Prasuti Tantra evum Stree Roga |
| Affiliation |
Rajiv Gandhi Government Post Graduate Ayurvedic College and hospital Paprola Distt kangra HP |
| Address |
Rajiv Gandhi Government Post Graduate Ayurvedic College and hospital Paprola Distt kangra Baijnath HP 176115 India
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9604283070 |
| Fax |
|
| Email |
nikitanagre0309@gmail.com |
|
|
Source of Monetary or Material Support
|
| HP Charak pharmacy, Rajiv Gandhi Government Post Graduate Ayurvedic College and
Hospital Paprola Distt Kangra, HP, 176115 Research Institute in ISM Jogindernagar, Distt Mandi HP |
|
|
Primary Sponsor
|
| Name |
Government of Himachal Pradesh |
| Address |
HP Secretariat Shimla, 171002, H.p. india |
| 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 |
| DrSeema Shukla |
Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola Distt Kangra HP |
OPD and IPD
Department of Prasuti
Tantra evum Stree
Roga,RGGPG Ayurvedic
College and Hospital
Paprola Distt Kangra HP
Kangra
HIMACHAL PRADESH
Kangra
HIMACHAL PRADESH |
9418008833
drseemanil@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee ( Human) Rajiv Gandhi Government Postgraduate Ayurvedic College and Hospital Paprola District Kangra Himachal Pradesh |
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
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Shatavari kwath, Reference: yogratnakar, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 24(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 10 Days, anupAna/sahapAna: Yes(details: -madhu), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Nitrofurantoin | Nitrofuranton 100 mg 12 hourly for 7 days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
i. Pregnant female patients. (13 to 38 weeks of GA).
ii. Clinically diagnosed patients which fell under symptomatic criteria of Garbhini
Mutrakrichhra
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
overall assessment will be seen in improvement in
subjective or objective criteria and also in
conception |
10 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
overall assessment will be seen in improvement in
subjective or objective criteria and also in
conception |
Twice in day for 10days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 2 |
|
Date of First Enrollment (India)
|
21/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
21/12/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
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
|
Research report will be soon published after the completion of trial 60 patients fulfilling the inclusion and exclusion criterias will be randomly selected from the OPD and IPD of department of Prasuti Tantra evum Stri Roga , RGGPG Ayurvedic College and Hospital Paprola Distt Kangra HP. Patients will be divided into 2 groups of 30 each .1. Patient will be managed with shatavari kawath 48 ml bd for 10 days . Drug free follow up will be 15 days of completion of trial Result will be assessed on the basis of subjective and objective criterias |