EFFECT OF INDIVIDUALIZED HOMOEOPATHIC MEDICINES IN FIFTY MILLESIMAL POTENCY IN ABNORMAL UTERINE BLEEDING WITH IT’S MIASMATIC ANALYSIS IN REPRODUCTIVE AGE GROUP FEMALES: A PROSPECTIVE STUDY
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- of intervention.
Study Overview
Brief Summary
Abnormal uterine bleeding (AUB;ICD-11-GA2Y) is a most common gynaecological symptom that describes irregularities in the menstrual cycle involving frequency, regularity, duration, and volume of flow outside of pregnancy. A normal menstrual cycle has a frequency of 24 to 38 days and lasts 2 to 7, with 5 to 80 millilitres of blood loss. Variations in any of these 4 parameters constitute abnormal uterine bleeding. It encompasses heavy menstrual bleeding, irregular menstrual bleeding and intermenstrual bleeding. Among them, HMB is the common conditions which affects 14-25% of women of reproductive age, with menorrhagia as the most common presentation about 32% followed by polymenorrhoea in 14%, metrorrhagia in 9% and menometrorrhagia in 4% of patients. AUB accounts for one third of outpatients who visits gynaecology OPD. This open label, single arm, prospective study is aimed to evaluate the role of Individualised Homoeopathic Medicines (IHMS) in fifty millesimal scale in the management of abnormal uterine bleeding in reproductive age group females(18 to 49 years). Study is planned to be conducted at The Calcutta Homoeopathic Medical College and Hospital. Study has a target to achieve a sample of 34 patients. Primary outcome assessment will be done by using PBAC Score and secondary outcome is to see changes in Short Form-36 Health Survey Questionnaire 1.0; to detect the predominant miasm in cases with Abnormal uterine bleeding (AUB); and to shortlist the most frequently indicated homoeopathic medicines in the treatment of AUB; all to be measured at baseline, and every month up to 6 months. The score obtained by the patients will be compared and result will be analysed as per appropriate statistical methods and interference will be done thereafter.
Study Design
- Study Type
- Interventional
- Allocation
- Not Applicable
- Masking
- Not Applicable
Eligibility Criteria
- Ages
- 18.00 Year(s) to 49.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •Patients fitting in the definition of AUB cases [(ICD-11-GA2Y)] more than 6 months.
- •Patients with age varying from 18 to 49 years.
- •Patients who can read or understand English, Bengali, Hindi.
Exclusion Criteria
- •Patient not willing to participate in study.
- •Pregnant, Puerperal women, Lactating mothers.
- •Patients having IUCD in situ.
- •Non-menstrual & non uterine causes for bleeding (Foreign bodies, genital malignancy, abortion, post coital).
- •Patients having haemoglobin less than 8 gm/dl [44].
- •Patients already undergoing any other treatment for AUB or any chronic diseases especially in last 6 weeks.
- •Patients already diagnosed of unstable psychiatric illness or other systemic diseases affecting quality of life.
- •Patients having any habits of substance abuse and addiction.
- •Simultaneous participation in any other clinical trial.
Outcomes
Primary Outcomes
of intervention.
Time Frame: At baseline, every 4 weeks, up to 6 months
To see changes in Pictorial Blood Assessment Chart (PBAC) Score after 6 months
Time Frame: At baseline, every 4 weeks, up to 6 months
Secondary Outcomes
- 1. To detect the predominant miasm in cases with Abnormal uterine bleeding (AUB).(2. Changes in Short Form-36 Health Survey Questionnaire 1.0.)