Skip to content

Ashiposhak vati for Premenstrual syndrome

Open labeled interventional clinical trial to evaluate effect of Asthipohak Vati tablet in the management of Premenstrual Syndrome(PMS)

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/05/033405
Enrollment
30
Registered
2021-05-05
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Health Condition 1: E35- Disorders of endocrine glands in diseases classified elsewhere Health Condition 2: E34- Other endocrine disorders

Interventions

Intervention1: Asthiposhak vati: 2 tablets orally twice a day with milk or water after food for 60 days Follow up 30 days Control Intervention1: not applicable: Not applicable

Sponsors

Shree Dhootpapeshwar Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Relief in pain in premenstrual period Improvements in low back ache constipation 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

Countries

India

Contacts

Public ContactDr Asokan V

Parul institute of Ayurveda

mrkarkare@gmail.com09422515717

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026