Homeopathic treatment of painful menses

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2023
INTERVENTION: Intervention1: Individualized homeopathic medicines in centesimal potencies plus concomitant care: Intervention is planned as administering the indicated homeopathic medicines in centesimal potencies (CH). Each dose will consist of 4 cane sugar globules no. 40 moistened with the indicated medicine (preserved in 90% v/v ethanol), to be taken orally on clean tongue with empty stomach; dosage and repetition depending upon the individual requirement of the cases. Patients will be advised to refrain from handling the globules or from eating, drinking, smoking or brushing teeth within 30 minutes of taking the globules and will be asked to suck the globules rather than simply swallowing those. All the medicines and sundry items will be procured from a Good Manufacturing Practice (GMP) certified firm. Every subject will receive psychological counselling regarding nutritious diet, adequate fluid, maintenance of regimen and hygienic measures and reassurance. Hot water compresses will be advised over the pelvic region at the time of menstrual cramps. Consuming tobacco in any form and alcohol will be advised to avoid. Physical activity will be encouraged and the subjects will be advised to be present for monthly follow‐ups. Frequency of administration of the medicine: Once or twice a day as required. Duration of therapy: 3 months. Control Intervention1: Identical‐looking placebos plus concomitant care: This group will receive placebos, identical in appearance with the verum. Each dose will consist of 4 cane sugar globules no. 40 moistened with 90% v/v ethanol, to be taken orally on clean tongue with empty stomach; dosage and repetition will be maintained depending upon the individual requirement of the cases. All sundry items will be procured from a Good Manufacturing Practice (GMP CONDITION: Health Condition 1: N944‐ Primary dysmenorrhea PRIMARY OUTCOME: 0‐10 numeric rating scale measuring intensity of painTimepoint: Day 1 and day 2 of menstruation for 3 consecutive months SECONDARY OUTCOME: Dysmenorrhoea Symptom Interference Scale (DSI)Timepoint: Every month, up to 3 months Frequency of taking PCM or NSAIDs as rescue remediesTimepoint: Every month, up to 3 months Measure yourself medical outcome profile 2 (MYMOP‐2)Timepoint: Every month, up to 3 months INCLUSION CRITERIA: 1. Female patients age between 12 years to 45 years. 2. Patients suffering from PD, pain score of 4‐9 on NRS. (ICD‐10 code N94.4) 3. Menstrual pain that hampers the day to activity of life. 4. Patients having menstrual pain which may radiate to back or thigh. 5. Female willing to provide a written informed consent voluntarily; illiterate people will be interviewed by the investigators maintaining adequate privacy to fill up the scales or questionnaires
Epistemonikos ID: 09ae96a7c77469ccd575b5383d629c01dd2dda46
First added on: Feb 20, 2024