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Clinical efficacy of self-designed Chaihu Guizhi Decoction on patients with liver Qi stagnation depression and its effect on tryptophan metabolism pathway and intestinal microflora induced by inflammatory factors

Clinical efficacy of self-designed Chaihu Guizhi Decoction on patients with liver Qi stagnation depression and its effect on tryptophan metabolism pathway induced by inflammatory factors

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200055834
Enrollment
Unknown
Registered
2022-01-20
Start date
2022-01-14
Completion date
Unknown
Last updated
2023-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

Interventions

The experimental group:Self-made Chaihu Guizhi decoction combined with sertraline hydrochloride
The control group:Sertraline hydrochloride

Sponsors

The First Affiliated Hospital of Guangxi University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria of depression in DSM-IV; Depressive attack is given priority to with low mood, not commensurate with its situation, can be from moping to distraught, even numb, serious can appear hallucinations, delusions and other psychotic symptoms, some cases of anxiety and motor agitation significant performance; 2. Meet the criteria of TCM syndrome diagnosis of depression liver Qi stagnation syndrome; Refer to the People's Republic of China Chinese medicine industry standard "Chinese medicine disease diagnosis and Curative Effect standard" liver Qi stagnation type depression diagnosis standard: depression not free, low spirit, good taixi. Or wan Ruffian, belching frequency and other diseases. Thin white tongue coating, pulse string. May have depression anger, more sorrow and joy, sorrow and other emotional injuries and injuries; 3. Hamilton Depression Scale (HAMD) score of 24 items >= 20 and <35; 4. Those aged between 18 and 65; 5. those who have not taken antidepressants or those who have taken antidepressants but have stopped taking them for two weeks; 6. Signed informed consent.

Exclusion criteria

Exclusion criteria: 1.The patient has post-traumatic stress disorder, eating disorder, obsessive-compulsive disorder (OCD) at (or within 6 months); 2.Patients with schizophrenia or bipolar disorder type or type (manic or manic episode history); 3.Patients met the criteria for drug or alcohol abuse within the month prior to the interview, and drug or alcohol dependence within the month prior to the interview; 4.The patient meets any of the following requirements: the patient has the intention to commit suicide within 1 month prior to the interview and has no specific plan; Committed suicide within 6 months prior to the interview; According to the investigators' analysis, there was a clear risk of suicide; 5.Patients who did not have sufficient effect of continuous use of different classes of antidepressants at sufficient doses and in a timely manner; 6.Patients who received electroconvulsive therapy within 6 months prior to the interview; 7.Patients allergic to serotonin reuptake inhibitors; 8.Patients with serious heart disease, kidney disease, neuropathy, cerebrovascular disease, liver disease, bleeding, metabolic disease and pulmonary dysfunction; 9.If the investigator determines that the patient has any serious disease, the patient should be excluded; 10.Women could not be pregnant, breast-feeding, or planning to conceive during the study period. All women had to be surgically removed during menopause or permanently (hysterectomy, oophorectomy, or bilateral salpingectomy) or determined that there was no risk of pregnancy; 11.Patients with systemic inflammatory diseases; 12.Patients with obvious mental behavior abnormalities; 13.Patients with obvious laboratory abnormalities; 14.Patients who have already participated or will participate in the drug observation study within 30 days.

Design outcomes

Primary

MeasureTime frame
Clinical curative effect;

Secondary

MeasureTime frame
TCM syndrome effect;Interleukin 6;Tumor necrosis factor-a;indoleamine2,3-dioxygenase1, IDO;5-HT/TRY;KYN/TRY;Intestinal flora;

Countries

China

Contacts

Public ContactCai Lun

The First Affiliated Hospital of Guangxi University of Chinese Medicine

zaozhi322@163.com+86 13768302934

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026