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Clinical Trials/CTRI/2024/07/070148
CTRI/2024/07/070148
Not yet recruiting
Not Applicable

An open labelled randomised controlled clinicalstudy to evaluate the efficacy of Ksheerbala taila yoni Pichu(vaginal tampon) given in 9th month of pregnancy to Achieve sukhaprasava (normal Vaginal delivery)

DrSmirti Mishra1 site in 1 country42 target enrollmentStarted: July 17, 2024Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
DrSmirti Mishra
Enrollment
42
Locations
1
Primary Endpoint
Effect of ksheerbala taila yoni pichu (vaginal tampon) in 9thmonth of pregnancy to achieve sukhaprasava (normal vaginal delivery)

Overview

Brief Summary

This is open labelled randomised controlled clinical study. The aim of this study to evaluate the efficacy of Ksheerbala Taila Yoni Pichu (vaginal tampon) to achieve sukhprasava.Total 42 participants will be enrolled in 2 groups (21 in each group)group A will be treated with Ksheerbala Taila Yoni and group B will be observed without yoni pichu of Ksheerbala Taila with required standard of care.the age group for study is 22yrs to 35 yrs pregnant female with GA 36 completed weeks.The final conclusion will be drawn on the basis of statistical methods.

Study Design

Study Type
Interventional
Allocation
Other
Masking
None

Eligibility Criteria

Ages
22.00 Year(s) to 35.00 Year(s) (—)
Sex
Female

Inclusion Criteria

  • All primigravida with age group between 22yrs to 35yrs with gestation age 36 completed weeks with cephalic presentation with adequate liquor.

Exclusion Criteria

  • Multipara Garbhopdravas like pregnancy induced hypertension (PIH) anemia cardiac disease Patient having garbhavyapadas like intrauterine growth retardation oligohydromnios ,placenta previa.

Outcomes

Primary Outcomes

Effect of ksheerbala taila yoni pichu (vaginal tampon) in 9thmonth of pregnancy to achieve sukhaprasava (normal vaginal delivery)

Time Frame: Twice in a week till edd by lmp(approx 4 weeks)

Secondary Outcomes

  • To observe the adverse effect of ksheerbala taila yoni pichu(Twice in a week till EDD by lmp(approx 4 weeks))

Investigators

Sponsor
DrSmirti Mishra
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Smirti Mishra

Dr. D.Y. Patil College Of Ayurved And Research Centre,Pimpri,Pune

Study Sites (1)

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