Clinical study of DMH Syrup and Tablets in Problems before Menstruation

Clinical Assessment of DMH Syrup and DMH Tablets in Pre-menstrual Syndrome - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/03/064639

Enrollment

Registered

2024-03-21

Start date

Unknown

Completion date

Unknown

Last updated

2024-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: F322- Major depressive disorder, singleepisode, severe without psychotic features Health Condition 2: N943- Premenstrual tension syndrome

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1.Provision of signed and dated informed consent prior to any study-specific procedures. 2. Healthy females in the age group of 19-45 years with a history of psychological or somatic signs and symptoms of Pre-menstrual syndrome (PMS) 3. Females with regular menstrual cycles of 21-35 days (based on history) 4. Not on any hormonal therapy during and one month prior to the trial. 5. Willing to practice birth control methods other than hormonal contraception (barrier/condoms) during study period (as applicable) 6. Willing to follow study related procedures.

Exclusion criteria

Exclusion criteria: Gynaecological conditions like history of any malignancy or organic lesions like genital tuberculosis, polyps, fibroids, endometriosis etc.Patients presenting with irregular menstrual cycle.Currently pregnant or breastfeeding.Planning pregnancy in next 3-4 months.Not willing to practice birth control methods other than hormonal contraception (oral contraceptive pill) during the course of the trial.Requirements of any prohibited concomitant medications (Oestrogen/Progesterone/ etc)

Design outcomes

Primary

Measure	Time frame
Reduction in psychological and somatic symptoms of premenstrual syndrome like Irritability, Mood swings, Periodic cramps after the administration of DMH syrup and DMH tablet after 90 daysTimepoint: 90 days	—

Secondary

Measure	Time frame
To evaluate the impact of DMH syrup & tablet on change in Qol of women with Pre-menstrual syndrome Improvement in lab parameters like CBC (ESR), Hormonal Levels & Urinalysis (assessed from Baseline to End of Study) Safety assessment basis adverse event reporting & løb parameters (LFT & RFT) o assess palatability & tolerability of products after 90 days of interventionTimepoint: 90 days	—

Countries

India

Contacts

Public ContactDr Anupama V

Sri Kalabyraveshwara Swamy Ayurvedic Medical College And Research Centre Bangalore

dr.anupama.v@gmail.com9845442660

Outcome results