Ashiposhak vati for Premenstrual syndrome
- Conditions
- Health Condition 1: E35- Disorders of endocrine glands in diseases classified elsewhereHealth Condition 2: E34- Other endocrine disorders
- Registration Number
- CTRI/2021/05/033405
- Lead Sponsor
- Shree Dhootpapeshwar Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement in the clinical features and relief of PMSTimepoint: The outcomes will be measured after screening at Base Line (BT) after 1 month and 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
- Secondary Outcome Measures
Name Time Method Relief in pain in premenstrual period <br/ ><br>Improvements in low back ache constipation <br/ ><br>Timepoint: The outcomes will be measured after screening at Base Line BT after 1 month and 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