Effectiveness of Individualised Homoeopathic medicine in alleviating the symptoms of intramural fibroid in women of age group 18-40 years-A Prospective, Single arm clinical study

The present study titled “Effectiveness of Individualised Homoeopathic Medicine in Alleviating the Symptoms of Intramural Fibroid in Women of Age Group 18–40 Years – A Non-randomised, Prospective, Single Arm, Clinical Study” is designed to evaluate the role of individualized homoeopathic medicines in symptomatic relief of intramural fibroids. Uterine fibroids are the most common benign tumors in women of reproductive age, with intramural fibroids being the most frequent subtype. Conventional management, including surgery, hormonal therapy, and uterine artery embolization, is often associated with adverse effects, high cost, and limitations in preserving fertility. Since existing studies on fibroids in homoeopathy are limited and most have not focused exclusively on intramural fibroids, there is a need for structured clinical evaluation in this group.

The primary objective of this study is to assess the improvement in symptoms using the Uterine Fibroid Symptom and Quality of Life (UFS-QOL) scale before and after homoeopathic treatment. The secondary objectives include evaluating changes in the size of the fibroid through ultrasonography and identifying the most frequently indicated homoeopathic remedies. This is a non-randomised, prospective, single arm clinical study with a sample size of 40 patients, calculated using Cochran’s formula with adjustment for a 10% dropout rate. The duration of the study will be 12 months, including six months of enrollment and six months of follow-up.

Eligible participants will be women aged 18–40 years with ultrasonographically confirmed intramural fibroids less than 5 cm in size, presenting with symptoms and willing to give informed consent. Cases with complications, malignancy, severe systemic illness, psychiatric disorders, or pregnancy will be excluded. Individualised homoeopathic medicines will be prescribed after detailed case taking and repertorization, in potencies suited to the patient’s susceptibility. Outcomes will be measured primarily by change in UFS-QOL scores and secondarily by change in USG findings. Data will be analyzed using the intention-to-treat approach, and statistical significance will be set at p < 0.05.

The study will be conducted at Nehru Homoeopathic Medical College & Hospital, New Delhi. Pharmacovigilance will be ensured throughout the trial, with all adverse events documented and reported. This study aims to provide evidence on whether individualized homoeopathic medicines can offer a safe, effective, and non-invasive treatment option for alleviating the symptoms of intramural fibroids, thereby improving the quality of life in affected women.