| CTRI Number |
CTRI/2025/03/081676 [Registered on: 05/03/2025] Trial Registered Prospectively |
| Last Modified On: |
28/02/2025 |
| 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
|
Effect of swadamstabala yoga and Trapusadi yoga in Garbhini mutrakricchra w.s.r to UTI in pregnancy |
|
Scientific Title of Study
|
“A Comparative Clinical Study To Evaluate the Efficacy of Trapusadi Yoga and Swadamstrabala Yoga in Garbhini Mutrakricchra 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 Ambika |
| Designation |
Post graduate resident |
| Affiliation |
Dr. N A magdum Ayurvedic hospital |
| Address |
Dr N A Magadum Ayurvedic hospital Dept. Of PTSR OPD no. 1 Ankali,tq Chikodi dist.Belagavi
Belgaum
KARNATAKA
591213
India |
| Phone |
8073756472 |
| Fax |
|
| Email |
Ambikamarutisakole@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepali koli |
| Designation |
Professor |
| Affiliation |
Dr N A Magadum Ayurvedic hospital |
| Address |
Dr N A Magadum Ayurvedic hospital Dept. Of PTSR OPD no. 1 Ankali,tq Chikodi dist.Belagavi
Belgaum
KARNATAKA
591213
India |
| Phone |
8975953456 |
| Fax |
|
| Email |
drdeepali5119@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrAmbika |
| Designation |
Post graduate resident |
| Affiliation |
Dr.N A Magadum Ayurvedic hospital |
| Address |
Dr N A Magadum Ayurvedic hospital Dept. Of PTSR OPD no. 1 Ankali,tq Chikodi dist.Belagavi
Belgaum
KARNATAKA
591213
India |
| Phone |
8073756472 |
| Fax |
|
| Email |
Ambikamarutisakole@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr N A Magadum Ayurvedic Medical Colleges hospital and Researchcentre Ankali 591213 Tq chikodi dist Belagavi |
|
|
Primary Sponsor
|
| Name |
Dr Ambika |
| Address |
Dr N A Magadum Ayurvedic Medical College hospital and Research centre Ankali 591213 tq Chikodi dist.Belagavi |
| Type of Sponsor |
Private 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 |
| Dr Ambika |
Dr N A Magadum Ayurvedic Medical hospital |
PTSR Department OPD no 1 Dr N A Magadum Ayurvedic Medical College hospital and Research centre, Ankali 591213 Tq Chikodi Dist Belagavi
Belgaum
KARNATAKA |
8073756472
ambikamarutisakole@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DrNAMAMC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O233||Infections of other parts of urinary tract in pregnancy. Ayurveda Condition: GARBINIROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Trapusadi yoga, Reference: Harita Samhita in Garbhopadrav chikistsa (51 /11), Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -Tandulodaka), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Swadamstabala yoga, Reference: Rasaratnasamucchya, in Vandhya chikitsaadhikar (22/92) , Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -Ushnodaka), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant women presenting with signs and symptoms of mutrakricchra w.s.r to UTI in pregnancy
Patients willing for the trial
Pregnant Patients with gestational age of 16 to 36 weeks
Laboratory investigations suggesting of UTI in pregnancy |
|
| ExclusionCriteria |
| Details |
Pregnancy associated any other systemic disorders like HTN, Diabetes, Gestational diabetes, Eclampcia.
Immuno-compromised patients |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Presence of, Sadaha mutra (Burning micturation), Saruja mutra (painful micturation), Kricchra mutrata (difficulty in micturation), Muhur-muhur mutrata (increased frequency of micturation) |
Before treatment and after treatment on 15th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Absence of, Sadaha mutra (Burning micturation), Saruja mutra (painful micturation), Kricchra mutrata (difficulty in micturation), Muhur-muhur mutrata (increased frequency of micturation) |
Before treatment and after treatment |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
13/03/2025 |
| 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 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
|
The present study Titled “A COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF TRAPUSADI YOGA AND SWADAMSTRABALA YOGA IN GARBHINI MUTRAKRICCHRA W.S.R TO UTI IN PREGNANCY” will be conducted on 60 subjects with 30 in each group with mentioned objective and subjective parameters. One group will be treated with Trapusadi yoga and another group with Swadamstrabala orally with Tandulodaka ushnodaka respectively. assesment of patient will be done before the treatment and after treatment (15th day) |