Study to Test the Safety and Effectiveness of Veinflo Cream and Capsules for People with Varicose Veins

An Open-Label, Single-Arm, Single-Center Pilot Study To Evaluate The Efficacy And Safety Of Veinflo Cream And Veinflo Capsules In Patients With Siraj Granthi (Varicose Veins) - Nil

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/12/078627

Enrollment

Registered

2024-12-27

Start date

Unknown

Completion date

Unknown

Last updated

2025-02-03

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

Conditions

Health Condition 1: I839- Asymptomatic varicose veins of lower extremities

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age- Male or female participants aged between 18 and 65 years. 2. Diagnosis-Participants diagnosed with Stage C1 or mild Stage C2 varicose veins according to the CEAP classification system. 3. Symptom Severity- • Visual Analog Scale (VAS) score of =3 (indicating at least mild-to-moderate pain). • Aberdeen Varicose Vein Questionnaire (AVVQ) score of 8–16 (indicating mild to-moderate symptom severity). 4. Ability to Comply-Willingness and ability to comply with the treatment regimen, follow-up visits, and study procedures. 5. Informed Consent: Participants must provide signed and dated informed consent

Exclusion criteria

Exclusion criteria: 1.Advanced Varicose Veins: Participants with Stage C3 or higher varicose veins (e.g-edema, skin changes, or ulceration) 2. Complications: • History of deep vein thrombosis (DVT). • Active or recurrent venous ulcers. • Recent vascular surgery (within the last 6 months). 3. Comorbidities: • Significant systemic illnesses, including uncontrolled diabetes, autoimmune diseases, or kidney, liver, or cardiovascular disorders. • Severe obesity (BMI greater than 35). 4. Pregnancy and Lactation: Pregnant or breastfeeding women, or women planning to conceive during the study period. 5. Hypersensitivity- Known allergy to any component of Veinflo Cream or Veinflo Capsules. 6. Recent Clinical Trial Participation- Participation in any other clinical trial within the past 30 days. 7. Psychiatric or Cognitive Conditions: Conditions that impair the ability to give informed consent or follow study instructions.

Design outcomes

Primary

Measure	Time frame
1. To evaluate the efficacy of Veinflo Cream and Veinflo Capsules in reducing the severity of symptoms associated with Siraj Granthi (Varicose Veins). This will be assessed using: o Visual Analog Scale (VAS): Reduction in pain intensity with a target improvement of at least 2 points on a 10-point scale by Day 14. o Aberdeen Varicose Vein Questionnaire (AVVQ): Reduction in symptom severity, with a target improvement of at least 4 points on a 100-point scale by Day 14. 2. To assess the improvement in the appearance of varicose veins, including a reduction in discolouration and swelling, as documented through photographic evidence.Timepoint: Day-0,Day-7,Day-14	—

Measure

Time frame

1. To evaluate the efficacy of Veinflo Cream and Veinflo Capsules in reducing the severity of symptoms associated with Siraj Granthi (Varicose Veins). This will be assessed using: o Visual Analog Scale (VAS): Reduction in pain intensity with a target improvement of at least 2 points on a 10-point scale by Day 14. o Aberdeen Varicose Vein Questionnaire (AVVQ): Reduction in symptom severity, with a target improvement of at least 4 points on a 100-point scale by Day 14. 2. To assess the improvement in the appearance of varicose veins, including a reduction in discolouration and swelling, as documented through photographic evidence.Timepoint: Day-0,Day-7,Day-14

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Secondary

Measure	Time frame
1. To evaluate the impact of Veinflo Cream and Veinflo Capsules on participants’ quality of life (QoL) as assessed using a validated QoL questionnaire. 2. To determine the safety profile of the investigational products by monitoring: o Frequency and severity of adverse events (AEs). o Incidence of serious adverse events (SAEs) related to the products. 3. To assess participant compliance with the treatment regimen through Subject Diary Card and drug accountability.Timepoint: Day-0,Day-7,Day-14	—

Measure

Time frame

1. To evaluate the impact of Veinflo Cream and Veinflo Capsules on participants’ quality of life (QoL) as assessed using a validated QoL questionnaire. 2. To determine the safety profile of the investigational products by monitoring: o Frequency and severity of adverse events (AEs). o Incidence of serious adverse events (SAEs) related to the products. 3. To assess participant compliance with the treatment regimen through Subject Diary Card and drug accountability.Timepoint: Day-0,Day-7,Day-14

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Countries

India

Contacts

Public ContactMs Arpita Malgi

SAMAHITHA RESEARCH SOLUTIONS

satyalm@samahitha.com9739001749

Outcome results