A Study of Chinese Medicine Treating Depression

NCT02873234 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 4600

Last updated 2016-08-19

No results posted yet for this study

Summary

Chinese Medicine syndrome differentiation has been a prevalent therapy in China for thousands of years. It is based on patients' symptoms, pulse, tongue and coating on the tongue. Therefore, the syndrome of patients and corresponding Traditional Chinese Medicine (TCM) may vary.

This multicenter prospective cohort studies the efficiency and safety of TCM compared with antidepressants. A total number of 4600 cases with primary depression are expected to be collected and divided into 3 cohorts based on the patients' requirement and choices. Patients in one group will receive TCM, and patients in the other two groups will respectively receive antidepressants only and integrated treatment of TCM and antidepressants. This study has 2 phases: treating period and the follow-up.

The main purpose of this long-term study is to evaluate the efficiency of TCM compared with antidepressants in reducing relapse and suicide rate, changing lifestyle, improving patient compliance as well as the safety.

Conditions

Interventions

DRUG

Traditional Chinese Medicine

Participants are treated with TCM twice per day according to syndrome differentiation. For example, the syndrome of one participant with depression is kidney deficiency. He will take Zishui Qinggan Yin twice per day before the breakfast and dinner.

DRUG

Antidepressants

Participants are treated with different antidepressants. The dosage, frequency and duration are determined according to guideline.

Sponsors & Collaborators

  • Guang'anmen Hospital of China Academy of Chinese Medical Sciences

    collaborator OTHER
  • Beijing HuiLongGuan Hospital

    collaborator OTHER
  • The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

    collaborator OTHER
  • First Affiliated Hospital of Heilongjiang Chinese Medicine University

    collaborator OTHER
  • The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine

    collaborator OTHER
  • Shandong University of Traditional Chinese Medicine

    collaborator OTHER
  • Capital Medical University

    collaborator OTHER
  • Xiamen Hospital of Traditional Chinese Medicine

    collaborator OTHER
  • Wu Xi Hospital of Traditional Chinese Medicine

    collaborator UNKNOWN
  • The Third Affiliated Hospital of Beijing University of Chinese Medicine

    lead OTHER

Principal Investigators

  • Qisheng Tang, MD, PHD · The Third Affiliated Hospital of Beijing University of Chinese Medicine

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2020-05-31
Completion
2020-05-31

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02873234 on ClinicalTrials.gov