Efficacy of individualized homoeopathic medicines in the treatment of varicose veins - a randomized placebo controlled trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Improvement in symptoms of varicose veins and quality of life of patients
Study Overview
Brief Summary
Varicose veins are a common chronic venous disorder associated with pain, swelling, heaviness, and cosmetic concerns. Conventional treatments include compression therapy, sclerotherapy, and surgery, but these approaches may have limitations, recurrence, or side effects. This randomized placebo-controlled trial aims to evaluate the efficacy of individualized homoeopathic medicines in improving symptoms and quality of life of patients with varicose veins. Eligible participants will be randomized to receive either individualized homoeopathic medicines or placebo over a specified treatment duration, and outcomes will be assessed using standardized clinical parameters and validated quality-of-life questionnaire.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 30.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Clinically diagnosed patients with varicose veins, patients willing to participate in study and providing written informed consent.
Exclusion Criteria
- •Associated comorbidities: Patients with associated medical conditions like any severe systemic illness, chronic communicable/non-communicable diseases, moderate to severe acute infectious condition, or any organ failure; Any vascular conditions that may impact findings of study including e.g. Atherosclerosis, Deep Vein Thrombosis, history of CVA, Peripheral Artery Disease, or any hypercoagulable state; Patients with the history of taking any medication for varicose veins within a period of 2 weeks before starting study; Special Population: Pregnant and lactating women, paediatric and geriatric patients.
Outcomes
Primary Outcomes
Improvement in symptoms of varicose veins and quality of life of patients
Time Frame: After inclusion, patients will be followed-up preferably after 2 weeks, 1 month, 2 months and 3 months from inclusion, as and when required. Patients visits may vary depending upon individualized therapy and patients clinical condition, except final visit at 3 months. VCSS scale and AVVQ questionnaire will be applied at the time of inclusion and at the completion of follow-up period, i.e., 3 months. Changes in symptomatology and scores will be noted and analysed.
Secondary Outcomes
- Identify most frequently used homoeopathic medicines in treating varicose veins(At inclusion, patient clinical condition will be analysed & individualized homoeopathic medicines or placebo will be prescribed to the subject for varicose veins. Frequency of each drug prescribed in study will be analysed to find out drugs frequently used drugs to treat varicose veins. After inclusion, patients will be followed-up preferably after 2 weeks, 1 month, 2 months & 3 months from inclusion, as & when required depending upon individualized therapy & patients clinical condition.)
Investigators
Dr Meenakshi Gupta
Sri Ganganagar Homoeopathic Medical College Hospital and Research Institute