The Efficacy of Combination of Traditional Tibetan and Remote Ischemic Conditioning on High Altitude Polycythemia

High Altitude Polycythemia Clinical Trial

Official title:

A Randomized Controlled Trial of the Efficacy of Combining Traditional Tibetan and Remote Ischemic Conditioning on High Altitude Polycythemia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06082583
• Other study ID #: HAPC
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: November 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: October 2023
• Source: Capital Medical University
• Contact: Yuan Wang, M.D.
• Phone: +86-135 8156 7815
• Email: wilma0106[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A multicenter, randomized controlled trial was designed to evaluate the effectiveness and safety of the comprehensive traditional Tibetan medicine program combined with remote ischemic conditioning on high altitude polycythemia.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients with high-altitude polycythemia aging 18 to 65 years.

Exclusion Criteria:

• Allergic to Tibetan medicine ingredients;
• Inappropriate to receive Tibetan medicine treatment and/or remote ischemic conditioning.

Related Conditions & MeSH terms

• Altitude Sickness
• High Altitude Polycythemia
• Polycythemia

Intervention

Device:
• Remote Ischemic Conditioning
Remote ischemic conditioning conducted by an electric auto-control device will be performed twice a day for 14 days, each session including 5-min ischemia and 5-min reperfusion.

Drug:
• Tibetan Medicine (Shiliu Jianwei Powder, Ershiwuwei Yuganzi Pills, Qiwei Tiexue Pill)
Comprehensively Tibetan medicine for 28 days, including Shiliu Jianwei Powder, Ershiwuwei Yuganzi Pills and Qiwei Tiexue Pill, dosage of which are 1.5g daily.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Capital Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of effective treatment	The hemoglobin levels decreased =20% after treatment compared to pre-treatment.	Baseline and 1 month after treatment.