Post-stroke DepressionEarly Phase 1NCT03147053
Efficacy and Safety of Jiedu Tongluo Granules for Post-stroke Depression
A Early Phase 1 study testing Jiedu Tongluo granules in people with Post-stroke Depression, run by Xiyuan Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Post-stroke Depression
- What is being tested?
- Jiedu Tongluo granules
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 1 siteChina
- Study dates
- 27 Apr 2017to 24 Jan 2018
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Beijing
About this study
Official title: The Efficacy and Safety of Jiedu Tongluo Granules on Patients With Post-stroke Depression: a Double-blind, Randomized and Placebo-controlled Trial
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
- Being tested
- Jiedu Tongluo granules, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jiedu Tongluo granulesDrug
Also called The treatment group
Patients in this group were administered the Jiedu Tongluo granules, 3.9mg/bag, 2 times/day for 8 weeks.
PlaceboDrug
Also called The control group
Patients in this group were administered the placebo, 3.9mg/bag, 2 times/day for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Jiedu Tongluo granules | Experimental | Patients in this group were administered the Jiedu Tongluo granules . Receives: Drug: Jiedu Tongluo granules |
| Placebo | Placebo comparator | Patients in this group were administered the placebo . Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 4weeks,8weeks
Change of Barthel Index (BI) From Baseline
The daily activities will be measured using Barthel Index(BI)
Measured: 4weeks,8weeks
Secondary outcomes (2)
Change of National Institute of Health stroke scale（NIHSS）From Baseline
Neurological function mainly measured by NIHSS
Measured: 4weeks,8weeks
The stroke diagnosis and evaluation criteria of Traditional Chinese Medicine（TCM）from baseline
To evaluate patients' syndrome by TCM scale
Measured: 4weeks,8weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2017
- Study start27 Apr 2017
- Primary completion7 Jul 2017
- Study completion24 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-stroke DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xiyuan Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jianxun Liu, Study director, xiyuan hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03147053
- Sponsor's protocol ID
- XiyuanH
- Status last verified
- Apr 2017
- First submitted
- 1 May 2017
- Last updated
- 21 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 29747670
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Jiedu Tongluo Granules on Patients With Post-stroke Depression: a Double-blind, Randomized and Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT03147053
- Acronym / sponsor ID
- XiyuanH
- Conditions
- Post-stroke Depression
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Xiyuan Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Study start
- 27 Apr 2017 (actual)
- Primary completion
- 7 Jul 2017 (actual)
- Study completion
- 24 Jan 2018 (actual)
- First posted
- 10 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Jiedu Tongluo granules | Experimental | Drug: Jiedu Tongluo granulesPatients in this group were administered the Jiedu Tongluo granules . |
| Placebo | Placebo comparator | Drug: PlaceboPatients in this group were administered the placebo . |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Jiedu Tongluo granulesAlso: The treatment groupPatients in this group were administered the Jiedu Tongluo granules, 3.9mg/bag, 2 times/day for 8 weeks. | Drug | Jiedu Tongluo granules |
| PlaceboAlso: The control groupPatients in this group were administered the placebo, 3.9mg/bag, 2 times/day for 8 weeks. | Drug | Placebo |
Primary outcome
Change of 17-item Hamilton Depression Scale( HAMD-17) From Baseline
Time frame: 4weeks,8weeks
Depression symptoms are mainly measured by the 17-item Hamilton Depression Scale (HAMD-17)
Change of Barthel Index (BI) From Baseline
Time frame: 4weeks,8weeks
The daily activities will be measured using Barthel Index(BI)
2 secondary outcomes
Change of National Institute of Health stroke scale（NIHSS）From Baseline
Time frame: 4weeks,8weeks
The stroke diagnosis and evaluation criteria of Traditional Chinese Medicine（TCM）from baseline
Time frame: 4weeks,8weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2019.
- Derived from this study: PubMed 29747670Zhao 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.
- Individual participant dataSharing planned: Undecided
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Post-stroke Depression
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jianxun Liu study director
xiyuan hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Jiedu Tongluo granules in people with Post-stroke Depression, run by Xiyuan Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of 17-item Hamilton Depression Scale( HAMD-17) From Baseline (time frame: 4weeks,8weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03147053, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2019.