Efficacy and Safety of Jiedu Tongluo Granules for Post-stroke Depression

NCT03147053 | Completed Early Phase 1

• 1 other identifier: XiyuanH
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

To explore the efficacy and safety of Jiedu Tongluo granules for post stroke depression. A randomized, double-blind, placebo-controlled clinical trial was designed. The treatment group was administered the Jiedu Tongluo granules, while the control group was administered the placebo.

Conditions

Post-stroke Depression

Outcome Measures

Primary Outcomes (2)

• Change of 17-item Hamilton Depression Scale( HAMD-17) From Baseline

  Depression symptoms are mainly measured by the 17-item Hamilton Depression Scale (HAMD-17)

  4weeks,8weeks

• Change of Barthel Index (BI) From Baseline

  The daily activities will be measured using Barthel Index(BI)

  4weeks,8weeks

Secondary Outcomes (2)

• Change of National Institute of Health stroke scale（NIHSS）From Baseline

  4weeks,8weeks

• The stroke diagnosis and evaluation criteria of Traditional Chinese Medicine（TCM）from baseline

  4weeks,8weeks

Other Outcomes (1)

• The change of cytokines IL-6、 IL-8 in serum from baseline

  4weeks,8weeks

Study Arms (2)

Jiedu Tongluo granules

EXPERIMENTAL

Patients in this group were administered the Jiedu Tongluo granules .

Drug: Jiedu Tongluo granules

Placebo

PLACEBO COMPARATOR

Patients in this group were administered the placebo .

Drug: Placebo

Interventions

Jiedu Tongluo granules DRUG

Patients in this group were administered the Jiedu Tongluo granules, 3.9mg/bag, 2 times/day for 8 weeks.

Also known as: The treatment group

Jiedu Tongluo granules

Placebo DRUG

Patients in this group were administered the placebo, 3.9mg/bag, 2 times/day for 8 weeks.

Also known as: The control group

Placebo

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of stroke, with neurological deficits symptoms;
• Clinical diagnosis of depression, according to the Diagnostic and Statistical Manual of Mental Disorders-IV （DSM-IV）or Chinese Classification and Diagnostic Criteria of Mental Disorders-3(CCMD-3), the score is between 7 to 24 by 17-item Hamilton Depression;
• Age of 45 to 80 years old;
• The patient is conscious, cooperation, without aphasia and severe cognitive impairment after acute phase of stroke;
• Without psychiatric disease history or family history of psychosis before stroke;
• No hormones and psychotropic drugs were used within 1 month before enrollment;
• capacity to provide written consent.

You may not qualify if:

• With brain organic disease such as brain tumors;
• Had a history of psychiatric illness or depression before stroke;
• Combined with severe liver, kidney, hematopoietic system disorder;
• Poor glycemic control and insulin-dependent diabetes;
• Participate in any clinical trial or taking antidepressant treatment 1 month prior to baseline;
• Pregnant or breast feeding;
• History of sensitivity to Chinese medicine ingredients.

Sponsors & Collaborators

• Xiyuan Hospital of China Academy of Chinese Medical Sciences: lead

Study Sites (1)

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Beijing, China

Location

Related Publications (1)

• Zhao AM, Qiu WR, Mao LJ, Ren JG, Xu L, Yao MJ, Bilinksi K, Chang D, Liu JX. The efficacy and safety of Jiedu Tongluo granules for treating post-stroke depression with qi deficiency and blood stasis syndrome: study protocol for a randomized controlled trial. Trials. 2018 May 10;19(1):275. doi: 10.1186/s13063-018-2633-4.

  PMID: 29747670 DERIVED

Study Officials

• Jianxun Liu

  xiyuan hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2017
• First Posted: May 10, 2017
• Study Start: April 27, 2017
• Primary Completion: July 7, 2017
• Study Completion: January 24, 2018
• Last Updated: August 21, 2019

Record last verified: 2017-04

Locations

CN (1)