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Clinical Trials/CTRI/2025/04/085775
CTRI/2025/04/085775Not yet recruitingPhase 2/3

Effect of Gandharvahasthadi yamakam in primary dysmenorrhea

Dr Sneha K1 site in 1 country36 target enrollmentStarted: May 10, 2025Last updated:

Trial Snapshot

Phase
Phase 2/3
Status
Not yet recruiting
Sponsor
Enrollment
36
Locations
1
Primary Endpoint
Reducing pain in primary dysmenorrhea

Study Overview

Brief Summary

This single-arm trial aims to investigate the effectiveness of Gandharvahasthadi Yamakam in alleviating the symptoms of primary dysmenorrhea in subjects aged 18-35 years .The study involves 36 participants who will be given 12ml of Gandharvahasthadi Yamakam from the 22nd day of one menstrual cycle to the 3rd day of the next cycle. Assessments will be taken before teatment, post-intervention (on the 4th day of the cycle), and at follow-up assessment (after 4 weeks) to evaluate the potential benefits of this Ayurvedic medicine in reducing pain and associated symptoms primary dysmenorrhea.

Study Design

Study Type
Interventional
Allocation
Na
Masking
None

Eligibility Criteria

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

Inclusion Criteria

  • 1.Subjects with regular menstrual cycle of 28-30 days interval 2.Age group between 18-35 years 3.Subjects satisfying diagnostic criteria asper SOGC.

Exclusion Criteria

  • 1.Subjects who are planning for pregnancy 2.Known case of systemic illness 3.Dysfunctional uterine bleeding 4.Structural abnormality of reproductive system 5.Lactating women 6.Pelvic pathology reported in USG •Subjects with mandagni assessed using agnibala assessment tool •Subjects having mridu koshta assessed using koshta assessment tool.

Outcomes

Primary Outcomes

Reducing pain in primary dysmenorrhea

Time Frame: First assessment before treatment | Second assessment on the 4th day of menstrual cycle after intervention | Third assessment is follow-up assessment after 4 weeks

Secondary Outcomes

  • Reducing associated symptoms in primary dysmenorrhea(First assessment before treatment)

Investigators

Sponsor
Dr Sneha K
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Dr Sneha K

PNNM Ayurveda Medical College and Hospital,Cheruthuruthy

Study Sites (1)

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