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

Sponsor
Capital Medical University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06082583
Collaborator
(none)
300
Enrollment
2
Arms
26
Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: Remote Ischemic Conditioning
  • Drug: Tibetan Medicine (Shiliu Jianwei Powder, Ershiwuwei Yuganzi Pills, Qiwei Tiexue Pill)
 Phase 2/Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomized Controlled Trial of the Efficacy of Combining Traditional Tibetan and Remote Ischemic Conditioning on High Altitude Polycythemia
Anticipated Study Start Date :
Nov 1, 2023
Anticipated Primary Completion Date :
Dec 31, 2025
Anticipated Study Completion Date :
Dec 31, 2025

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Tibetan Medicine Group

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.
Experimental: Tibetan Medicine-Remote Ischemic Conditioning Group

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.
Other Names:
  • An electric auto-control device to perform remote ischemic conditioning.

    • 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.

    Outcome Measures

    Primary Outcome Measures

    1. The incidence of effective treatment [Baseline and 1 month after treatment.]

      The hemoglobin levels decreased ≥20% after treatment compared to pre-treatment.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Capital Medical University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ji Xunming,MD,PhD, Principal Investigator, Capital Medical University
    ClinicalTrials.gov Identifier:
    NCT06082583
    Other Study ID Numbers:
    • HAPC
    First Posted:
    Oct 13, 2023
    Last Update Posted:
    Oct 13, 2023
    Last Verified:
    Oct 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Altitude Sickness
    Polycythemia

    Study Results

    No Results Posted as of Oct 13, 2023