Homoeopathic treatment of Premenstrual Syndrome

Phase 2

Completed

• Conditions: Health Condition 1: N943- Premenstrual tension syndrome

• Registration Number: CTRI/2020/11/028796
• Lead Sponsor: ational Institute of Homoeopathy Ministry of AYUSH Govt of India

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-03-09
• Last Update Posted: 26 June 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 60

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Shortened Premenstrual Assessment Form (SPAF)Timepoint: Baseline, 1 month, 2 month, 3 month

Secondary Outcome Measures

Name	Time	Method
participant-rated Premenstrual Tension <br/ ><br>Syndrome Visual Analogue Scale (PMTS-VAS)Timepoint: Baseline, 1 month, 2 month, 3 month;Premenstrual Tension Syndrome <br/ ><br>Observer Rating Scale â?? Revised (PMTS-OR)Timepoint: Baseline, 1 month, 2 month, 3 month