Effect of Punarnavadi Guggulu as a treatment of symptoms occuring before menses

Phase 2

Not yet recruiting

Conditions: Problem related to unspecified psychosocial circumstances. Ayurveda Condition: not specified,

Registration Number: CTRI/2021/03/032219

Lead Sponsor: Parul Institute of Ayurvda

Brief Summary: Premenstrual syndrome (PMS) encompasses a variety of emotional and physical symptoms that occur from several days to weeks before the onset of menstrual flow. Presently, Premenstrual syndrome is recognized as a psycho-neuroendocrine disorder of unknown etiology.

Symptoms disrupting the premenstrual period if left untreated may lead to PMDD-premenstrual dysphoric disease which is a more severe form of manifestation of the symptoms related to PMS may have disastrous effects in the form of suicidal thoughts, panic disorders, lack of interest in daily activities and relationships. This may have grave consequences on the socio-economic of life thereby reducing the qualiy of life of the patient.

Modern medicine has not zeroed in on a specific cause, but has suggested a number hypothesis to explain the possible pathophysiology. They are as under: Diminished progesterone levels, Decreased synthesis of serotonin, Withdrawal of endorphins from the brain during luteal phase, Reduced Gamma amino butyric acid levels.

By and large symptoms complex bears a similarity to the Samprapti of Shotha mentioned by Ayurvedic classics. The hypothesis therefore is formed that the drugs used in Shotha vyadhi would be helpful in terminating the Samprapti and alleviating the symptoms in PMS. The hypothesis is substantiated by the fact that the intervention drug chosen for this study- Punarnavadi guggulu from Shotha-adhikara of Bhaishajya Ratnawali is indeed found to be useful in treating PMS. It is therefore proposed to undertake this study to create an evidence for its usage by vaidyas.

Assessment criteria- PMTS-OR

Intervention - Punarnavadi Guggulu 4 tab (500mg each) twice a day with luke warm water, After meal, for 2 cycles and 1 cycle for observation

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: Female

Target Recruitment: 30

Inclusion Criteria

Age 18-40 years Irrespective of marrital status Regular cycle Symptoms should appear at definite time in luteal phase of the cycle.

Exclusion Criteria

Women aged below 18 and above 40 years Diagnosed psychiatric disorder Irregular cycle Any organic pelvic pathology Any known major systemic illness Diabetes PCOS Metrorrhagia symptoms should not persist after 5 days of menstrual cycle symptoms shuold not reoccur within the 1st 13 days.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To subside premenstrual symptoms	30 days

Secondary Outcome Measures

Name	Time	Method
relief in the symptoms of dysmenorrhea	30 days

Trial Locations

Locations (1): Parul Ayurveda Hospital
🇮🇳
Vadodara, GUJARAT, India
Parul Ayurveda Hospital
🇮🇳Vadodara, GUJARAT, India
Dr Manjusha Karkare
Principal investigator
9422515717
mrkarkare@gmail.com