Homeopathic treatment of symptoms of menopause

Phase 2

Recruiting

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

Brief Summary: Menopause is the final menstrual period, and occurs at an average age of 51 years. Menopause is defined as the permanent cessation of menstrual cycles where pathological causes of this state can be diagnosed. Demographic data show that every year 25 million women worldwide experience menopause . Hormone replacement therapy is the standard treatment for early symptoms in post-menopausal women, but increases the risks of stroke, heart diseases, vaginal bleeding, nausea, vomiting, migraine, mastalgia, and breast cancer in older women. Menopausal symptoms have been treated with homoeopathic medicines for more than one and a half centuries. In spite of promising potentials of homoeopathic treatment of menopausal syndrome, it has remained anecdotal rather than being evidence-based. In this open, observational, multicentric, pre-post comparison clinical trial, 100 patients will be given individualized homoeopathic medicines to examine treatment effect over 6 months. Prior to that, psychometric validity of the translated Bengali versions of the Greene climacteric scale (GCS), Menopause rating scale (MRS), and Utian Quality of Life (UQOL) questionnaires will be tested. Results will be published in scientific journals.

Recruitment & Eligibility

Inclusion Criteria

Cases suffering from menopausal syndrome; i.e. cessation of menstruation for at least 1 year 2.
Age: 40-55 years 3.
Ability to read Bengali 4.
Patients giving written consent to participate.

Exclusion Criteria

Patients who had an artificial menopause and were on HRT 2.
Patients having history of breast or reproductive organ cancer 3.
Patients with psychiatric diseases.
Cases suffering from uncontrolled systemic illness or life-threatening infections 5.
Cases already undergoing homoeopathic treatment for any chronic disease 6.
Self-reported immune-compromised state.

Primary Outcome Measures

Name	Time	Method
Greene climacteric scale (GCS); translated Bengali version	At baseline and after 3 and 6 months

Secondary Outcome Measures

Name	Time	Method
Menopause rating scale (MRS); translated Bengali version	At baseline and after 3 and 6 months
Utian quality of life (UQOL) scale; translated Bengali version	At baseline and after 3 and 6 months

Locations (3): Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, Govt. of West Bengal
🇮🇳
Haora, WEST BENGAL, India
National Institute of Homoeopathy, Govt. of India
🇮🇳
Kolkata, WEST BENGAL, India
The Calcutta Homoeopathic Medical College and Hospital, Govt. of West Bengal
🇮🇳
Kolkata, WEST BENGAL, India
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, Govt. of West Bengal
🇮🇳Haora, WEST BENGAL, India
Amila Modak
Principal investigator
9433432025
amilamodak@gmail.com