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Clinical Trials/CTRI/2021/05/033405
CTRI/2021/05/033405RecruitingPhase 4

Open labeled interventional clinical trial to evaluate effect of Asthipohak Vati tablet in the management of Premenstrual Syndrome(PMS)

Shree Dhootpapeshwar Ltd0 sites0 target enrollmentStarted: TBDLast updated:
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Trial Snapshot

Phase
Phase 4
Status
Recruiting
Sponsor
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Inclusion Criteria

  • •1 Subjects irrespective of their marital status
  • •2 Women with regular cycle with symptoms of pre- menstrual syndrome, at around 25th day onwards of menstrual cycle, with symptoms extending not beyond 5th day of subsequent menstrual cycle.
  • •3 Women having a minimum PMTS score greater than or equal to 10 and VAS score greater than or equal to 1
  • •4 Be able and willing in the view of the investigator to comply with all study procedures

Exclusion Criteria

  • •1 Subjects aged above 40 years
  • •2 Unmarried or married subjects with irregular cycles
  • •3 Pregnant women
  • •4 Subjects on any type of OC Pills hormone containing medication since past 6 months IUCD ovulation induction or menstrual regularizers-since past 6 months
  • •5 Subjects with chronic debilitating ailments and on cortico steroid therapy
  • •6 Women with history of PID endometriosis and debilitating pathological conditions of the pelvic organs systemic diseases like diabetes mellitus bronchial asthma tuberculosis thyroid dysfunction with organic lesion benign or malignant growth of reproductive tract any degree of uterine prolapse and hypo-plastic uterus
  • •7 Women with congenital anomalies of genital organs
  • •8 Subjects with history of or diagnosed cases of psychosomatic ailments, Cognitive disorders, psychosis or neurosis, personality disorders
  • •9 Women with Urinary calculus
  • •10 Women taking any concomitant medicine for PMS will be excluded from the study

Investigators

Sponsor
Shree Dhootpapeshwar Ltd

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