| CTRI Number |
CTRI/2025/04/086069 [Registered on: 30/04/2025] Trial Registered Prospectively |
| Last Modified On: |
29/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical study to evaluate the effect of Ervarubeejadi Yoga Elixir in Managing Pittaj Mutrakrichha |
|
Scientific Title of Study
|
A Randomized controlled Clinical Study to Evaluate the Effect of Ervarubeejadi Yoga Elixir in Management of Pittaj Mutrakrichha W.S.R. to Lower Urinary Tract Infection |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NILL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rachana Madhukar |
| Designation |
PG Scholar |
| Affiliation |
Parul Institute of Ayurved and Research |
| Address |
Department of Prasuti Tantra Evum Stree Roga,Parul Institute of Ayurved and Research Parul University P.O Limda Vadodara Gujarat India Pincode-391760
Vadodara
GUJARAT
391760
India |
| Phone |
9981272718 |
| Fax |
|
| Email |
madhukardrrachana4@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manjusha Karkare |
| Designation |
Professor |
| Affiliation |
Parul Institute of Ayurved and Research |
| Address |
Department of Prasuti Tantra Evum Stree Roga,Parul Institute of Ayurved and Research Parul University P.O Limda Vadodara Gujarat India Pincode-391760
Vadodara
GUJARAT
391760
India |
| Phone |
9422515717 |
| Fax |
|
| Email |
karkaremr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rachana Madhukar |
| Designation |
PG Scholar |
| Affiliation |
Parul Institute of Ayurved and Reaerch |
| Address |
Department of Prasuti Tantra Evum Stree Roga,Parul Institute of Ayurved and Research Parul University P.O Limda Vadodara Gujarat India Pincode-391760
Vadodara
GUJARAT
391760
India |
| Phone |
9981272718 |
| Fax |
|
| Email |
madhukardrrachana4@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Rachana Madhukar Post Graduate Scholar Department of Prasuti Tantra Evum Stree Roga Parul Institute of Ayurved and Research Parul University P.O Limda Vadodara Gujarat India Pincode - 391760 |
|
|
Primary Sponsor
|
| Name |
Dr Rachana Madhukar |
| Address |
Department of Prasuti Tantra Evum Stree Roga Parul Institute of Ayurved and Research Parul University P.O Limda Vadodara Gujarat India Pincode-391760 |
| Type of Sponsor |
Other [Self ] |
|
|
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 Rachana Madhukar |
Khemdas Hospital |
OPD No.05 Department of Prasuti Tantra Evum Stree Roga Ground Floor Khemdas Hospital Parul Institute of Ayurved abd Research Parul University P.O Limda Vadodara Gujarat India Pincode- 391760 Vadodara Gujarat
Vadodara
GUJARAT |
9981272718
madhukardrrachana4@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PIAR-IECHR |
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: PITTAJAMUTRAKRUCCRAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Ervarubeejadi Yoga Elixir, Reference: Bhaishajya Ratnavali Chikitsa 34, Route: Oral, Dosage Form: Sharkara/ Syrup, Dose: 10(ml), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 5 Days, anupAna/sahapAna: No, Additional Information: - Ervarubeejadi Yoga is used for its Mutravirechaka (diuretic), Shothahara (anti-inflammatory), and Krimighna (antimicrobial) properties. It helps in clearing urinary pathogens, reducing inflammation, and promoting smooth urine flow. | | 2 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Syrup Renalka, Reference: NA, Route: Oral, Dosage Form: Sharkara/ Syrup, Dose: 10(ml), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 5 Days, anupAna/sahapAna: No, Additional Information: -Surup renalka is useful to treat lower UTI |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Diagnostic Patient of Pittaj Mutrakriccha which are similar to lower Urinary track infection like
Burning Micturation
Dysuria
Drequency of Micturation
Hematuria
|
|
| ExclusionCriteria |
| Details |
Known case of Renal calculi
Patient suffering from chronic and any other debiliating disease
Patient suffering from white discharge per vagina
Pregnant and Lactating woman suffering from LUTI |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in symptoms of mutrakrichhra like, Burning, Dysuria, Frequency and Hematuria |
BT- 0th Day
DT- 5th Day
AT-10th Day
1st 5days medicine will be given and 5days gap will be there and Asessment will be done on 10th Day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvemnt in Urine Routine and Microscopy and CBC values |
BT- 0th Day
DT- 5th Day
AT-10th Day
1st 5days medicine will be given and 5days gap will be there and Asessment will be done on 10th Day |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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)
|
04/06/2025 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This randomized controlled clinical trial aims to evaluate the efficacy of an Ayurvedic intervention in the management of Pittaja Mutrakrichra, a condition correlating with Lower Urinary Tract Infections (LUTIs). A total of 140 patients, aged between 18 to 40 years, presenting with key symptoms such as burning micturition (Sadahamutrata), dysuria (Sarujamutrata), increased frequency of micturition (Muhur-Muhurmutrata), and haematuria (Sarakta Mutrata), and scoring is equal around 6 on the subjective parameter scale, are selected and randomized into two groups: Group A (Trial group) and Group B (Control group). Participants receive medication for 5 days, followed by a 5-day observation period without medication. Assessments are conducted on Day 0 (BT), Day 5 (DT), and Day 10 (AT), using both subjective scores and objective parameters like urine microscopy, CBC, and RBS. Exclusion criteria include cases with renal calculi, chronic diseases, vaginal discharge, and pregnant/lactating women. Data is collected and analyzed statistically to assess the impact of the intervention. This study is conducted over 18 months, aiming to validate Ayurvedic management protocols for LUTIs through standardized clinical methodology |