NCT06245642

Compound Ciwujia Granules Treat Chronic Fatigue Syndrome

A Multi-center, Randomized, Double-blind, Positive Parallel Control Study of Compound Ciwujia Granules in the Treatment of Chronic Fatigue Syndrome (Spleen-kidney Deficiency Syndrome, Heart-spleen Deficiency Syndrome)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 235 (actual)
• Sponsor: Heilongjiang Quanle Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

To observe the improvement of Chalder scale score in patients with chronic fatigue syndrome treated by Compound Ciwujia Granules. Improvement =\[(baseline score - post-treatment score)/baseline score\]\*100%

Detailed description

After being informed of the study and potential risks, all subjects who have given informed consent undergo a 2-week screening period to determine eligibility, and on day 0, subjects who meet eligibility requirements will be randomly assigned in a double-blind way. The patients were treated with Compound Ciwujia Granules + Guipi Granules/placebo (experimental group) and Compound Ciwujia Granules/placebo + Guipi Granules (positive control group) at a ratio of 1:1 for 6 weeks. Compound Ciwujia Granules/placebo 8g per bag, 2 times a day, 1 bag each time, Guipi Granules, 3g per bag, taken with boiling water. 1 bag (3g) at a time, 3 times a day.

Conditions

• Chronic Fatigue Syndrome

Interventions

Type	Name	Description
DRUG	Compound Ciwujia Granules, Guipi Granules	Experimental group: Basic treatment + Compound Ciwujia Granules + Guipi Granules simulator orally for 6 weeks; Positive drug control group: basic treatment + Guipi Granules + Compound Ciwujia Granules simulant orally for 6 weeks.

Timeline

• Start date: 2024-03-19
• Primary completion: 2025-01-16
• Completion: 2025-01-16
• First posted: 2024-02-07
• Last updated: 2025-09-23

Locations

1 site across 1 country: China