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Homoeopathic treatment of Premenstrual Syndrome

Individualized Homoeopathic Medicines in Treatment of Premenstrual Syndrome: Double- blind, Randomized, Placebo-controlled, Pilot Trial

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/11/028796
Enrollment
60
Registered
2020-11-02
Start date
Unknown
Completion date
Unknown
Last updated
2023-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N943- Premenstrual tension syndrome

Interventions

Intervention1: Individualized homoeopathic medicines in centesimal potencies: Each dose shall consist of 6-8 globules (no. 20) of cane sugar, medicated with the indicated medicine (preserved in 90% v/
dosage and repetition depending upon the individual requirement of the cases. All medicines will be procured from a Good Manufacturing Practice (GMP)-certified firm. Duration of therapy: 3 months. Con

Sponsors

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

Eligibility

Inclusion criteria

Inclusion criteria: 1. Cases suffering from PMS for more than 3 months, diagnosed as per ICD-10 criteria 2. Patients taking oral contraceptive pills (OCPs) will be advised to stop pills till it exhaust for the ongoing cycle, followed by reassessment of PMS symptoms in the next cycle enrolment 3. Patients under hormonal replacement therapy (HRT) to be included after a washout period of 3 months 4. Literate patients; ability to read Bengali and/or English 5. Patients giving written consent to participate

Exclusion criteria

Exclusion criteria: 1. PMDD states 2. Patients underwent a hysterectomy and/or bilateral oophorectomy 3. Primary or secondary amenorrhoea 4. Change in hormone status (introduction of oestrogen and/or progestogen, amenorrhoea, pregnancy etc.) 5. Patients having a history of breast or reproductive organ cancer 6. Unevaluated gynaecological abnormalities; e.g. unexplained vaginal bleeding, cervical dysplasia, pelvic inflammatory diseases (PID) within one month, patients with suspicious adenomyosis, gross developmental defect or congenital abnormalities of the uterus etc. 7. Patients with psychiatric diseases 8. Cases suffering from uncontrolled systemic illness, life-threatening infections, or any vital organ failure 9. Patients insisting to use OCPs and HRT 10. Cases already undergoing homoeopathic treatment for any chronic purpose 11. Substance abuse and/or dependence 12.Self-reported immune-compromised state

Design outcomes

Primary

MeasureTime frame
Shortened Premenstrual Assessment Form (SPAF)Timepoint: Baseline, 1 month, 2 month, 3 month

Secondary

MeasureTime frame
participant-rated Premenstrual Tension Syndrome Visual Analogue Scale (PMTS-VAS)Timepoint: Baseline, 1 month, 2 month, 3 month;Premenstrual Tension Syndrome Observer Rating Scale â?? Revised (PMTS-OR)Timepoint: Baseline, 1 month, 2 month, 3 month

Countries

India

Contacts

Public ContactChintamani Nayak

National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India

drcnayak@gmail.com9433161854

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026