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An Exploratory Randomized, Double-blind, Placebo-controlled Study on Compound Ciwujia Granules in the Treatment of Depression (Heart-Spleen Deficiency Syndrome)
The purpose of this clinical trial is to evaluate the therapeutic efficacy and safety of Compound Ciwujia Granules in treating depression disorder (heart-spleen deficiency syndrome). The study primarily aims to address the following key questions: * Can Compound Ciwujia Granules effectively alleviate depressive symptoms in patients with heart-spleen deficiency syndrome? * What adverse reactions might participants experience while taking Compound Ciwujia Granules? Researchers will compare Compound Ciwujia Granules to a placebo (a look-alike substance that contains no drug) to see if Compound Ciwujia Granules works to treat depression disorder. Participants are required to complete the following procedures: 1. Take Compound Ciwujia Granules or placebo twice daily for 8 weeks; 2. Continue concomitant SSRIs throughout the treatment period; 3. Return to the hospital for scheduled assessments at Week 4 and Week 8; 4. Complete a 4-week follow-up period after the 8-week treatment phase.
Age
18 - 65 years
Sex
ALL
Healthy Volunteers
No
Start Date
October 1, 2025
Primary Completion Date
April 20, 2026
Completion Date
May 30, 2026
Last Updated
September 15, 2025
60
ESTIMATED participants
Compound Ciwujia Granules
DRUG
placebo
DRUG
Lead Sponsor
Shanghai Mental Health Center
Collaborators
NCT06793397
NCT06878859
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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