Homeopathic treatment of vaginal symptoms after menopause

Phase 2

Recruiting

Conditions: Postmenopausal vulvo-vaginitis

Registration Number: CTRI/2018/04/013272

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 shows that every year 25 million women worldwide experience menopause. An estimated 75% of women experience at least one episode of vulvovaginal candidiasis (VVC) during their lifetimes. Nearly 45% of women will experience two or more episode. Candida albicans is responsible for 85% to 90% of vaginal yeast infections. Other species of candida such as C. glabrata, and C. tropicalis can cause vulvovaginal symptoms and to be resistant to therapy. 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. Individualized homoeopathic treatment may have considerable potential to offer in successful treatment of vulvo-vaginal symptoms in post-menopausal women, but has remained under-researched till date. In this open, observational, multicentric, pre-post comparison clinical trial, 100 patients suffering from post-menopausal vulvo-vaginitis will be given individualized homoeopathic medicines to examine treatment effect over 3 months. Prior to that, psychometric validity of the translated Bengali versions of the vulvo-vaginal symptoms questionnaire (VSQ) and Utian Quality of Life (UQOL) questionnaire will be tested. Results will be published in scientific journals.

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Female

Target Recruitment: 100

Inclusion Criteria

Postmenopausal women suffering from vulvo-vaginal symptoms for at least last 3 months 2.
Age: 50-60 years 3.
Ability to read Bengali 5.
Patients giving written consent to participate 6.
Any standard or other CAM therapy, if ongoing, discontinued for at least 1 month.

Exclusion Criteria

Patients with known vulvar dermatoses including: Lichen Sclerosus, Lichen Planus, Psoriasis, Behcetâ€™s disease, Hidradenitis Suppurativa, Anorectal Crohnâ€™s disease, or Genital Herpes 2.
Patients who had an artificial menopause and were on HRT 3.
Patients having history of breast or reproductive organ cancer 4.
Major gynecological surgery in last 6 months 5.
Patients with psychiatric diseases.
Cases suffering from uncontrolled systemic illness or life-threatening infections 7.
Cases already undergoing homoeopathic treatment for any chronic disease 8.
Self-reported immune-compromised state.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Translated Bengali version of vulvo-vaginal symptom questionnaire (VSQ)	Baseline and after 3 months

Secondary Outcome Measures

Name	Time	Method
Translated Bengali version of Utial Quality of Life (UQOL) questionnaire	Baseline and after 3 months

Trial Locations

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