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Acupuncture plus Chinese herbal formula for post-stroke depression: A protocol for randomized controlled trial

Acupuncture plus Chinese herbal formula for post-stroke depression: A protocol for randomized controlled trial

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300074818
Enrollment
Unknown
Registered
2023-08-17
Start date
2023-09-01
Completion date
Unknown
Last updated
2023-08-21

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

Conditions

post-stroke depression

Interventions

The treatment group :Acupincture: Main points: Yintang, Baihui, Shuigou, Neiguan (bilateral), Sanyinjiao (affected side)
matching points: Jiquan, Chize, Weizhong, Hegu, Qiuxu, Tiantu, based on the patient s accompanying symptoms of stroke. 30 mintues for one time, and once a day for four weeks. Chinese Herbal medicine:
The control group:Patients in the control group will receive orally administered Fluoxetine (FLX) for four weeks. The dose is initiated at 10mg per day and the different optimal dose will be escalated

Sponsors

the Second Affiliated Hospital of Heilongjiang University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria for stroke, and confirm the lesion and nature of stroke by CT or MR; 2. Between 40 and 80 years old, gender is not limited; 3. Meet the relevant diagnostic criteria for depression; Hamilton Depression Scale score (HAMD-24 items) was used as an evaluation index of depression status, with a total score of > 8 points; 4. Depressive symptoms appeared after the stroke, and the depressive state lasted for more than 2 weeks; 5. Deny personal and family history of positive mental and consciousness disorders before the onset of the disease; 6. There is no evidence of other causes of depression; 7. Have not taken any therapeutic psychotropic drugs; 8. Voluntarily participate in this study and agree to sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Severe mental disorder, cognitive dysfunction, confusion, speech dysfunction; 2. Patients with positive history and family history of mental disorders, or recent history of taking antidepressants; 3. Patients with severe multiple organ diseases such as lung, liver and kidney, combined with unstable vital signs; 4. People with coagulation disorders; 5. Students with a lower education level of primary school or below; 6. Patients who can not tolerate acupuncture treatment and are seriously dizzy; 7. Not accepting interviewers for various reasons.

Design outcomes

Primary

MeasureTime frame
Hamilton Depression Scale (HAMD);

Secondary

MeasureTime frame
TCM syndrome scoring criteria (TCMSSC);The modified Edinburgh and Scandinavia Stroke Scale (MESSS);The drop points rate of Hamilton Depression Scale (DprHAMD);

Countries

China

Contacts

Public ContactXiao Gao

the Second Affiliated Hospital of Heilongjiang University of Chinese Medicine

gaoxiaohlj@163.com+86 139 4505 6365

Outcome results

None listed

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