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Search / Trial NCT06245642

Compound Xiwujia Granules Treat Chronic Fatigue Syndrome

Launched by HEILONGJIANG QUANLE PHARMACEUTICAL CO., LTD. · Feb 5, 2024

Trial Information

Current as of July 23, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial is studying a treatment using Compound Xiwujia Granules for people with Chronic Fatigue Syndrome (CFS). The main goal is to see if this treatment can help improve fatigue levels, which will be measured using the Chalder scale—a tool that assesses how tired a person feels. Participants will be asked to complete the scale before and after treatment to check for improvements.

To be eligible for this study, participants must be between the ages of 18 and 70 and have been diagnosed with Chronic Fatigue Syndrome according to Western medical standards. They should also meet certain criteria from traditional Chinese medicine related to energy levels. However, individuals with severe mental health issues, serious health problems, or those who are pregnant or breastfeeding cannot participate. If you decide to join, you will need to sign a consent form and attend regular visits for assessments and treatments as outlined in the study plan. This trial is currently not recruiting participants, so there will be more information available when it starts.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Meet the diagnostic criteria of Western medicine for chronic fatigue syndrome;
  • Meet the diagnostic criteria of spleen and kidney deficiency syndrome or heart and spleen deficiency syndrome of traditional Chinese medicine;
  • Chalder scale score greater than 12 points;
  • Age 18-70 years old, gender is not limited;
  • Agree to participate in this clinical study, voluntarily sign informed consent, and agree to participate in visits, examinations, and treatments according to the requirements of the research protocol.
  • Exclusion Criteria:
  • Combined with mental disorders such as severe anxiety and severe depression;
  • Secondary fatigue caused by drugs or other reasons;
  • Patients with serious primary diseases such as cardiovascular and cerebrovascular, liver, kidney and hematopoietic system, malignant tumors, and other serious complications; Abnormal liver and kidney function ALT, AST≥ 1.5 times the upper limit of normal value, Cr \> the upper limit of normal value;
  • Women who are pregnant, breastfeeding or who may become pregnant in the study and cannot use effective contraception;
  • Have received relevant treatment and may affect the observed effect indicators;
  • Suspected to have a history of drug abuse or other patients who do not meet the eligibility criteria;
  • Allergic physique and allergic to the drug;
  • Uncontrolled hypertension (DBP \> 100mmHg or SBP \> 160 mmHg);
  • Diabetic patients;
  • Those that the researcher thinks are not suitable for participating in this study.

About Heilongjiang Quanle Pharmaceutical Co., Ltd.

Heilongjiang Quanle Pharmaceutical Co., Ltd. is a leading pharmaceutical company based in China, dedicated to the research, development, and manufacturing of innovative healthcare solutions. With a strong focus on quality and efficacy, the company specializes in a diverse range of therapeutic areas, including oncology, cardiology, and infectious diseases. Committed to advancing medical science, Heilongjiang Quanle collaborates with various research institutions and healthcare professionals to conduct clinical trials aimed at delivering safe and effective treatments to patients. Through its robust pipeline and adherence to international regulatory standards, the company strives to enhance patient outcomes and contribute to global health advancements.

Locations

Shanghai, Shanghai, China

Patients applied

0 patients applied

Trial Officials

Xiaotian Zhang, Master

Principal Investigator

Principal Investigator

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported