Phase III clinical trial of Ningweiyixing in treatment for mild and moderate depression (qi and yin deficiency)

Efficacy and safety evaluation of Ningweiyixing in treatment for mild and moderate depression (qi and yin deficiency): A randomized, double-blind, double-dummy,placebo-controlled,fluoxetine-controlled multi-center Phase III clinical trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-IIR-17012569

Enrollment

Unknown

Registered

2017-09-04

Start date

2008-12-25

Completion date

Unknown

Last updated

2017-09-11

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

Conditions

Depression

Interventions

experiment group:Ningyuyixing

placebo-controlled:placebo

fluoxetine-controlled:fluoxetine

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria of CCMD-3 onset of depression; 2. Meet the diagnostic criteria of qi and yin deficiency syndrome; 3. 17 items HAMD=14 scores=24 scores and the depression item in HAMD?=2 scores; 4. The subjects were informed and voluntarily signed informed consent; 5. The subjects are among 18-65 ages and both sexuality; 6. The reducing rate of HAMD between screening and enrollment is less than 25%.

Exclusion criteria

Exclusion criteria: 1. serious suicidal tendencies; 2. Severe anxiety (HAMD anxiety score >21); 3. Severe and unstable primary diseases such as heart disease,liver and renal hematopoietic system damage; 4. Patients with epilepsy or Glaucoma; 5. Subjects who with drug of alcohol addiction; 6. Secondary depression of other mental or physical disease; 7. Take medicine like monoamine oxidase inhibitor, Alprazolam, Chlordiazepoxide, buspirone or Chinese medicine that is used for replenishing qi and yin with 1weeks; 8. Take medicine like fluoxetine or other anti-depression or Antipsychotics (such as risperidone, olanzapine); 9. Subjects who had bad compliance or is unsupervised; 10. Subjects who had drug allergy history or with allergic constitution; 11. Pregnant, breastfeeding and menstrual women; 12. Subjects who participated in clinical trials in recent 1 month or in phases II clinical trial of Shenweiningyu.

Design outcomes

Primary

Measure	Time frame
Hamilton's Depression Scale;	—

Secondary

Measure	Time frame
Reducing rate of Chinese Medicine syndrome;Clinical Global Impression;	—

Countries

China

Contacts

Public ContactGao Rui

Xiyuan Hospital, Affiliated hospital of China Academy of Chinese Medicine Science

258664350@qq.com+86 010 62835651

Outcome results

None listed

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