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Clinical Trials/CTRI/2023/07/055516
CTRI/2023/07/055516Not yet recruitingPhase 2

Comparative Clinical Study To Evaluate The Efficacy Of Brahmi Churna Capsule And Jatamansi Churna Capsule In Pre-Menstrual Syndrome.

Parul Institute Of Ayurveda1 site in 1 country60 target enrollmentStarted: January 8, 2023Last updated:
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Trial Snapshot

Phase
Phase 2
Status
Not yet recruiting
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
To subside Pre-Menstrual Symptoms
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

Premenstrual syndrome is recognized as a psycho-neuro-endocrine disorder of unknown aetiology PMS encompasses a wide variety of emotional and physical symptoms that occur from several days to week before the onset of menstrual flow Various hypotheses are postulated to explain the etiopathogenesis of PMS.

Brahmi churna is very effective in psycho-neuro-endocrinal symptoms which relieves that symptoms and improves quality life of female.

Patients will be assesed on the basis of

1 PMS self rating scale

2.PMS Observer rating scale

3.PMS Vas scale

Study Design

Study Type
Interventional
Allocation
Computer generated randomization
Masking
Open Label

Eligibility Criteria

Ages
18.00 Year(s) to 40.00 Year(s) (—)
Sex
Female

Inclusion Criteria

  • •Age between 18 yrs to 40 yrs of age irrespective of socio economic status and in good medical health
  • •Female subjects having regular menstrual cycle with cycle length of 21-35 days.
  • •Having a minimum PMTS score >10 and VAS score >1
  • •Symptoms should appear at definite time in luteal phase of the cycle.
  • •The subject should be symptomatic for a period of last 3 or more than 3 months.
  • •Symptoms should not persist beyond the 5th day of menstrual cycle.
  • •The subjects who are ready to follow the treatment protocol and sign the informed consent.

Exclusion Criteria

  • •Women aged below 18 and above 40 years
  • •Subject suffering from other acute or chronic psychiatric illness.
  • •Those with symptoms existing less than 3 menstrual cycles.
  • •Subjects suffering from organic brain diseases.
  • •Subjects under hormonal and psychiatric treatment.
  • •Subjects with premenstrual dysphoric disorder.

Outcomes

Primary Outcomes

To subside Pre-Menstrual Symptoms

Time Frame: 30 days

Secondary Outcomes

  • Improvement in quality of life.(The outcomes will be measured after screening at Base Line BT after 1 month & at the end of 2 months AT Assessment of clinical parameters will also be done at the end of the 3rd month after 1 month of medicine free period)

Investigators

Sponsor
Parul Institute Of Ayurveda
Sponsor Class
Research institution and hospital

Study Sites (1)

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