Ashiposhak vati for Premenstrual syndrome

Not Applicable

Recruiting

Conditions: Disorders of endocrine glands in diseases classified elsewhere. Ayurveda Condition: Pre-menstrual syndrome, (2) ICD-10 Condition: E34||Other endocrine disorders. Ayurveda Condition: Pre-menstrual syndrome,

Registration Number: CTRI/2021/05/033405

Lead Sponsor: Shree Dhootpapeshwar Ltd

Brief Summary: Premenstrual syndrome is recognized as a psycho-neuro-endocrine disorder of unknown aeitiology PMS encompasses a wide variety of emotional and physical symptoms that occur from several days to week before the onset of menstrual flow. Various hypotheses are postulated to explain the etiopathogenesis of PMS

Evidence strongly suggests that calcium and vitamin D deficiency and alteration in the metabolism of calcium and vitamin D are responsible for these luteal phase symptoms

In the present study propreitary medicine asthiposhak vati which is known to relieve symptoms related to calcium deficiency, is selected for the management of PMS It may have a positive effect on the calcium metabolism and thereby alter the pathology of PMS.

Patients will be asses ed on the basis of

1 PMS self rating scale

2.PMS Observer rating scale

3. PMS Vas scale

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Female

Target Recruitment: 30

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

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 PMS	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	Improvements in low back ache constipation

Trial Locations

Locations (2): KhemdasAyurveda Hospital
🇮🇳
Vadodara, GUJARAT, India
Parul Ayurveda Hospital
🇮🇳
Vadodara, GUJARAT, India
KhemdasAyurveda Hospital
🇮🇳Vadodara, GUJARAT, India
Dr Mauli Vaishnav
Principal investigator
9589788336
mauli.vaishnav86211@paruluniversity.ac.in