Homoeopathic treatment of irregular menses

Phase 2/3

Completed

Conditions: Irregular menstruation, unspecified,

Registration Number: CTRI/2022/04/041659

Lead Sponsor: D N De Homoeopathic Medical College and Hospital

Brief Summary: Prevalence of irregular menstrual cycle ranges from 81.7 to 96.3% and absenteeism from school due to menstrual discomfort ranges from 80.6 to 63.5%. Recent research suggested that homoeopathy is one of the most popular choices for women with various gynaecological disorders. This trial was aimed at differentiating individualized homoeopathic medicines (IHMs) from identical-looking placebos in the treatment of menstrual irregularities in women of the early reproductive age group. A four-month, double-blind, randomized (1:1), placebo-controlled trial was conducted on 92 females with menstrual irregularities at D. N. De Homoeopathic Medical College and Hospital. Participants were randomized into either verum (IHMs, n = 46) or control (placebos; n = 46). The primary outcome measure was the proportion of participants between groups in whom menstrual irregularities could be corrected. The secondary outcome was MDQ (Menstrual Distress Questionnaire) and its subscales. All the outcomes were measured at monthly intervals of up to 4 months. Group differences were estimated on the intention-to-treat sample. After 4 months of intervention, the group difference in the primary outcome was non-significant statistically (P = 0.835). The improvement observed in the MDQ total score and subscales scores were higher in the IHMs group than in placebos, however, statistically non-significant in most of the occasions, except for the behavioural change subscale (P < 0.001). Pulsatilla nigricans was the most frequently prescribed medicine. Kentâ€™s Repertory and Complete were the most frequently used repertories. Overall the result remains inconclusive â€“ the analysis fails to demonstrate clearly that IHMs were effective beyond placebos in most of the outcomes. More appropriate outcome measures should be sought for future trials.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 92

Inclusion Criteria

Patients suffering from menstrual irregularities (ICD 10: N92.6) 2.
Differential diagnosis established by USG and other laboratory investigations as appropriate.
Age: 11-25 years.
Patients taking oral contraceptive pills will be considered for the study after giving a wash-out period of 1 month.
Literate patients, who can read and write in Bengali, and/or English.
Patients giving written informed consent to participate in the study.

Exclusion Criteria

Patients suffering from carcinoma of cervix, chronic tubo-ovarian mass, endometrial carcinoma, genital tuberculosis.
Vulnerable population â€“ unconscious, ambulatory, too sick for consultation, differently abled, terminally or critically ill patients, mentally incompetent people.
Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life- threatening illness affecting quality of life or any organ failure.
Blood haemoglobin level less than 7g/dl.
Participants with habits of tobacco chewing and/or smoking, alcoholism and/or any other form(s) of substance abuse and/or dependence.
Self-reported immune-compromised state.
Undergoing homeopathic treatment for any chronic disease within last 6 months.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The proportion of participants between groups in whom menstrual irregularities can be corrected	Baseline, after each menstrual cycle, up to 4 cycles

Secondary Outcome Measures

Name	Time	Method
Menstrual Distress Questionnaire (MDQ) score	Baseline, and after each menstrual cycle, up to 4 cycles

Trial Locations

Locations (1): D N De Homoeopathic Medical College & Hospital
🇮🇳
Kolkata, WEST BENGAL, India
D N De Homoeopathic Medical College & Hospital
🇮🇳Kolkata, WEST BENGAL, India
Usashi Nag
Principal investigator
8250807906
usashinag96@gmail.com