Clinical study of DMH Syrup and Tablets in Problems before Menstruatio
- Conditions
- Health Condition 1: F322- Major depressive disorder, singleepisode, severe without psychotic featuresHealth Condition 2: N943- Premenstrual tension syndrome
- Registration Number
- CTRI/2024/03/064639
- Lead Sponsor
- Dabur India Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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.
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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method To evaluate the impact of DMH syrup & tablet on change in Qol of women with Pre-menstrual syndrome <br/ ><br>Improvement in lab parameters like CBC (ESR), Hormonal Levels & Urinalysis (assessed from Baseline to End of Study) <br/ ><br>Safety assessment basis adverse event reporting & løb parameters (LFT & RFT) <br/ ><br>o assess palatability & tolerability of products after 90 days of interventionTimepoint: 90 days