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

October 8, 2023 updated by: Ji Xunming,MD,PhD, Capital Medical University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of effective treatment
Time Frame: Baseline and 1 month after treatment.
The hemoglobin levels decreased ≥20% after treatment compared to pre-treatment.
Baseline and 1 month after treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Capital Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2023

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

September 21, 2023

First Submitted That Met QC Criteria

October 8, 2023

First Posted (Actual)

October 13, 2023

Study Record Updates

Last Update Posted (Actual)

October 13, 2023

Last Update Submitted That Met QC Criteria

October 8, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HAPC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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