Homoeopathic treatment of Premenstrual Syndrome

Phase 2/3

Completed

Lead Sponsor: National Institute of Homoeopathy Ministry of AYUSH Govt of India

Brief Summary: Premenstrual syndrome (PMS) is one of the commonest problems in females of reproductive age group. This pilot trial aimed at testing the feasibility of future definitive trial and evaluated whether individualized homoeopathic medicines (IH) have a significant effect beyond placebo in PMS symptoms. A double-blind, randomized (1:1), placebo-controlled, parallel arms, a pilot trial will be conducted at National Institute of Homoeopathy, Kolkata, West Bengal, India. Patients received either IH (n=30) or identical-looking placebo (n=30) during the trial. Outcomes will be measured every month up to 3 months. Group differences will be estimated by intention-to-treat analysis. The trial results will enable us to understand the effect of homoeopathic medicines in PMS, the feasibility of conducting such trials in future and direction to the future studies.

Recruitment & Eligibility

Inclusion Criteria

Cases suffering from PMS for more than 3 months, diagnosed as per ICD-10 criteria 2.
Patients taking oral contraceptive pills (OCPs) will be advised to stop pills till it exhaust for the ongoing cycle, followed by reassessment of PMS symptoms in the next cycle enrolment 3.
Patients under hormonal replacement therapy (HRT) to be included after a washout period of 3 months 4.
Literate patients; ability to read Bengali and/or English 5.
Patients giving written consent to participate.

Exclusion Criteria

PMDD states 2.
Patients underwent a hysterectomy and/or bilateral oophorectomy 3.
Primary or secondary amenorrhoea 4.
Change in hormone status (introduction of oestrogen and/or progestogen, amenorrhoea, pregnancy etc.) 5.
Patients having a history of breast or reproductive organ cancer 6.
Unevaluated gynaecological abnormalities; e.g. unexplained vaginal bleeding, cervical dysplasia, pelvic inflammatory diseases (PID) within one month, patients with suspicious adenomyosis, gross developmental defect or congenital abnormalities of the uterus etc.
Patients with psychiatric diseases 8.
Cases suffering from uncontrolled systemic illness, life-threatening infections, or any vital organ failure 9.
Patients insisting to use OCPs and HRT 10.
Cases already undergoing homoeopathic treatment for any chronic purpose 11.
Substance abuse and/or dependence 12.Self-reported immune-compromised state.

Primary Outcome Measures

Name	Time	Method
Shortened Premenstrual Assessment Form (SPAF)	Baseline, 1 month, 2 month, 3 month

Secondary Outcome Measures

Name	Time	Method
participant-rated Premenstrual Tension	Syndrome Visual Analogue Scale (PMTS-VAS)
Premenstrual Tension Syndrome	Observer Rating Scale â€“ Revised (PMTS-OR)

Locations (1): National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India
🇮🇳
Kolkata, WEST BENGAL, India
National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India
🇮🇳Kolkata, WEST BENGAL, India
Sanjib Sahoo
Principal investigator
8159802601
pmsanjibsahoo970@gmail.com