A 3 month clinical trial of herbal medicine combination intended for topical application in patients with leg symptoms complaints due to chronic venous insufficiency: a double-blind randomized controlled trial

Not Applicable

Completed

• Conditions: Chronic venous insufficiency; Circulatory System; Venous insufficiency (chronic) (peripheral)

• Registration Number: ISRCTN54360155
• Lead Sponsor: ational Research University Project, Office of the Higher Education Commission (WCU-58-034-AS)

Brief Summary

2017 Results article in https://www.tci-thaijo.org/index.php/EAUHJSci/article/view/101887 results 2018 Results article in http://journalcra.com/sites/default/files/issue-pdf/28347.pdf results 2019 Results article in https://doi.org/10.15419/bmrat.v6i2.523 results 2019 Results article in http://dx.doi.org/10.5455/IJMRCR.Chronic-Venous-Disease-Thai-Patients results 2020 Abstract results in https://doi.org/10.1016/j.imr.2020.100558 Presented at KIOM-SAR 2020 International Research Conference (added 04/01/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-01-14
• Study Completion: 2016-12-31
• Last Update Posted: 17 January 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

Current inclusion criteria as of 15/12/2017:
Patients seeking advice at the surgery ambulatory clinics with at least 5 of the following symptoms:
1. Heavy leg
2. Pain in the leg
3. Sensation of leg swelling
4. Night cramp
5. Itching leg
6. Sensation of burning
7. Sensation of pins/needle in the leg
8. Presence of superficial varicose vein
9. Presence of spider veins 10. Presence of blood-clotting.

And must have been accurately diagnosed as chronic venous insufficiency by physician as per WHO- ICD10 Criteria and also being graded as appropriate staging of the chronic venous insufficiency stage as per the CEAP Criteria.

Previous inclusion criteria:
Patients seeking advice at the surgery ambulatory clinics with at least 5 of the following symptoms:
1. Heavy leg
2. Pain in the leg
3. Sensation of leg swelling
4. Night cramp
5. Itching leg
6. Sensation of burning
7. Sensation of pins/needle in the leg
8. Presence of superficial varicose vein
9. Presence of spider veins 10. Presence of blood-clotting.

Plus these patients must have at least one risk factor as follows :
1. Sibling history with presence of swollen leg, spider & varicose veins and ankle/leg ulcer
2. Long hours standing per day (=3 hours)
3. Long hours sitting per day (=3 hours)
4. No regular exercise
5. Smoker
6. Taking hormone replacement therapy and/or contraceptive (oral/injectable)

And must have been accurately diagnosed as chronic venous insufficiency by physician as per WHO- ICD10 Criteria and also being graded as appropriate staging of the chronic venous insufficiency stage as per the CEAP Criteria.

Exclusion Criteria

Patients with known history of:
1. ASA-exacerbated respiratory disease (AERD) and/or asthma
2. ASA-sensitivity and Rhinitis/Nasal Polyps
3. ASA and NSAIDs induce cutaneous reactions with Urticaria, Angioedema
4. ASA-induced anaphylactoid reactions with Hypotension, swelling, laryngeal edema, generalized pruritus, tachypnea
also:
5. Patients with known sensitivity or allergic to centenella asiaticosa or asiaticoside.
6. Patients with known sensitivity or allergic to acemannan and the aloe vera products

Study & Design

• Study Type: Interventional
• Study Design: Not specified