To evaluate the safety of sitcom forte tablet and sitcom cream in treatment of varicose veins

Study to evaluate the efficacy and safety of sitcom forte tablet euphorbia prostrata 100 mg and calcium dobesilate 500 mg and sitcom cream euphorbia prostrata dry extract Cream in treatment of varicose veins

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/12/038604

Enrollment

100

Registered

2021-12-14

Start date

Unknown

Completion date

Unknown

Last updated

2024-01-22

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

Conditions

Health Condition 1: I832- Varicose veins of lower extremities with both ulcer and inflammation

Interventions

Intervention1: Sitcom Forte Tablet: 1 tablet Twice Daily for 1 month. 1 tablet Once a day or Twice Daily for 2 months (As per clinical condition). Intervention2: Sitcom cream: To be applied locally

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patient is diagnosed with primary or symptomatic varicose veins and not indicated for any surgical intervention. 2.Patients is willing to participate in the current study and sign the informed consent form. 3.Patients is not on any other allopathic / herbal medication (oral or topical) for the treatment of varicose veins for last 7 days.

Exclusion criteria

Exclusion criteria: 1.Lactating women. Women in post –partum period of up to 6 weeks. 2.Patient having hypersensitive predisposition or hypersensitive to any of components of the study drug. 3.Clinically significant co-morbid condition that in the opinion of the investigator could affect patient.

Design outcomes

Primary

Measure	Time frame
1.Change in VVSymQ scores for symptoms (Pain in Legs, Swelling, Tingling, Numbness in legs and itching around veins). 2.Change in skin color. 3.Change in number and size of venous ulcers 4.Decrease in rate of Occlusion 5.Venous ulcer reduction 6.Venous Stasis changes 7.Overall Improvement in Disease (By Investigator and Patient) 8.Treatment Assessment (By Investigator and Patient) Timepoint: 2 months	—

Measure

Time frame

1.Change in VVSymQ scores for symptoms (Pain in Legs, Swelling, Tingling, Numbness in legs and itching around veins). 2.Change in skin color. 3.Change in number and size of venous ulcers 4.Decrease in rate of Occlusion 5.Venous ulcer reduction 6.Venous Stasis changes 7.Overall Improvement in Disease (By Investigator and Patient) 8.Treatment Assessment (By Investigator and Patient) Timepoint: 2 months

—

Secondary

Measure	Time frame
1.Number of Adverse Events during the study durationTimepoint: 3 months	—

Countries

India

Contacts

Public ContactDr Ashwin Porwal

Healing Hands Clinic

drashwinporwal@gmail.com9822347770

Outcome results

None listed

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