Vascular DementiaPhase 2NCT01475578
Study of STA-1 Capsule in Patients With Vascular Dementia (Marrow-Sea Deficiency)
A Phase 2 study testing STA-1 and Ergoloid Mesylates tablet in people with Vascular Dementia, run by Sinphar Pharmaceutical Co., Ltd at 5 sites in China.
Trial summary
The objectives of this phase II study of STA-1 capsule was to make preliminary evaluation on clinical efficacy and safety of STA-1 capsule in order that based on the dosage and study structure planned in this project, the dosage and study structure of phase III study can be confirmed. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Vascular Dementia
- What is being tested?
- STA-1 and Ergoloid Mesylates tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 5 sitesChina
- Study dates
- Mar 2002to Oct 2002
- Phase
- Phase 2
- 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
- Meeting criteria of dementia according to Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV)
- Meeting criteria of vascular dementia according to National Institute of Neurological Disorders and Stroke-Association Internationale pour la Recherche et l'Enseignement en Neurosciences (NINDS/AIREN)
- With Mini-Mental State Examination (MMSE score) ≦17 (illiteracy); ≦20 (elementary school); ≦24 (high school or above)
- With Hachinski's ischemic score (HIS) ≧7
- With marrow-sea deficiency from Chinese medicine's perspective
- Classified mild to moderate dementia based on MMSE score
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- With body weight 45 to 95 Kg
- Aged 45 to 80 years old (inclusive). Either gender is eligible. Female subjects must be postmenopausal (for at least 1 year) women without fertility
- Having signed informed consent form
- Correct understanding of pharmaceutical research and good compliance to study personnel's observation and evaluation
Who cannot join
- Dementia besides study indication based on DSM-IV and NINDS/AIREN, e.g. Alzheimer's disease, Lwey body disease, etc.
- With HIS < 7
- Diagnosed significant depression based on DSM-IV with score >8 or with other mental diseases/disorders
- With cognitive dysfunction caused by head impairment
- With medical history of epilepsy, encephalitis, or any other diseases that may result in dementia, e.g. Parkinson's disease, Huntington disease, Pick disease, etc. Patients with epilepsy attacked occasionally should be examined at the first visit by electroencephalography (EEG) and should be excluded from this study if by the test results are positive.
- With certain diseases that may interfere the evaluation of cognitive function, including abuse of alcohol, or DSM-IV diagnosed abuse of drugs or mental drugs in past 5 years. Severe anemia patients should also be excluded.
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- With severe mental dysfunction, e.g. hemiplegia, aphasia, visually and hearing impairment, etc.
- With cardiac disorder, e.g. heart rate ≦ 50 or ≧ 180 times/minute
- With supine or sitting Systolic blood pressure ≦ 100 or ≧ 180 mmHg
- With other disease, especially hepatic, renal, or cardiac disorders, e.g. ALT/SGPT or AST/SGOT > 3 times of upper limit of normal range, serum creatinine > 177 umol/L (2mg/dL), or congestive heart failure (cardiac function 2-4 in classification)
- With malignant neoplasm
- With thyroid dysfunction or syphilis
- Failed to control diabetes. Diabetes patients can not enter the study unless the status becomes stable through dietary modification, taking hypoglycemic agents, or receiving insulin.
- With asthma or chronic obstructive pulmonary disease
- With multiple neuritis
- With myasthenia gravis and amyotrophic
- With severe indigestion, or gastrointestinal obstruction, or gastric and duodenal ulcer, or other gastrointestinal diseases that can affect drug absorption
- With glaucoma
- Ever attending other clinical trials in past 30 days
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
Affiliated Hospital of Chengdu University of Traditional Chinese Medicines, China
Chengdu
Fujian Academy of Traditional Chinese Medicine
Fujian
Hospital (Traditional Chinese Medicine) Affiliated to Luzhou Medical College
Luzhou
Affiliated Hospital of Shaanxi Academy of Traditional Chinese Medicine,
Shaanxi
Xi'an Traditional Chinese Medicine Hospital
Xi'an
About this study
Official title: A Randomized, Double-Blind, Double-Dummy, Active-Controlled, Parallel, Comparative, Multicenter, Phase II Study to Evaluate the Efficacy and Safety of STA-1 Capsule in Patients With Vascular Dementia (Marrow-Sea Deficiency)
The objectives of this phase II study of STA-1 capsule was to make preliminary evaluation on clinical efficacy and safety of STA-1 capsule in order that based on the dosage and study structure planned in this project, the dosage and study structure of phase III study can be confirmed.
Read the detailed description
This phase II clinical trial was planned to be in double-blind, double-dummy, active-controlled, parallel, comparative, multicenter design. Two hundred and 40 eligible subjects were planned to be recruited by 5 study centers. The treatment period planned in the protocol was 3 months with 5 study visits including Randomization visit (Day 0), three post-treatment visits (1 and 2 months after Randomization visit and Final visit) and 1 follow-up visit made at 6 month after Randomization visit.
After subjects recruited by this study having read and singed the ICF, they were arranged to be collected information of demographics, medical history, allergy history, medication history, and concomitant medication. Laboratory and physical examination including vital signs were performed, and Hachinski Ischemia Score (HIS), Mini-Mental Status Examination (MMSE), and Classification of Marrow-Sea deficiency were evaluated to ensure subject's eligibility to enter this study. After the subjects were confirmed eligible, they were randomly assigned to either STA-1 or Ergoloid Mesylates group. Blessed-Roth Behavior Scale (BBS) and Activities of Daily Living (ADL) Scale were measured after subjects were randomized. These subjects were then dispensed study medications for 1-month use.
The eligible subjects were requested to bring back unused study medication, if any, to study centers at 1, 2, and 3 months (Final visit) after the Randomization visit. At these visits, measurements of MMSE, BBS, ADL scales, and Classification of Marrow-Sea deficiency were collected. Information concomitant medications and AEs were also recorded. Physical and laboratory examinations were performed at Final visit. Each subject was dispensed with study medications for his/her subsequent treatment period at month-1 and -2 visits. Unused study medications were collected with drug accountability documented. Subjects were dismissed from the study at the Final visit.
Subjects were measured MMSE, BBS, and ADL scales at 6 months after the Randomization visit if they were available for follow-up evaluations.
- Conditions
- Vascular Dementia
- Being tested
- STA-1, Ergoloid Mesylates tablet
- Keywords
- Vascular Dementia
- Medical subject headings
- Dementia, Vascular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STA-1Drug
STA-1 capsule (manufactured by Sinphar Tian-Li (Hangzhou) Pharm. Co., Ltd.; Batch number: 020121), 2 capsules/time, 3 times/day, orally
Ergoloid Mesylates tabletDrug
Ergoloid Mesylates tablet (manufactured by Tianjin Huajin Pharmaceutical Factory; Batch number: 011230), 2 tablets/time, 3 times/day, orally before meal
| Study group | Role | What they receive |
|---|---|---|
| STA-1 | Experimental | STA-1 capsule (Cistanche tubulosa), 2 capsules/time, 3 times/day, orally
Dummy Ergoloid Mesylates tablet (Placebo), 2 tablets/time, 3 times/day, orally Receives: Drug: STA-1 |
| Ergoloid Mesylates | Active comparator | Ergoloid Mesylates tablet, 2 tablets/time, 3 times/day, orally before meal
Dummy STA-1 capsule (Placebo), 2 capsules/time, 3 times/day, orally Receives: Drug: Ergoloid Mesylates tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from Baseline in Mini-Mental State Examination (MMSE)
MMSE were used to evaluate subject's change in orientation, attention and calculation, immediate recall and delayed memory, and language ability before and after treatment.
Measured: Month 1, Month 2, , Month 3, , Month 6
Changes from Baseline in Blessed-Roth Behavior Scale (BBS)
Measured: Month 1, Month 2, , Month 3, , Month 6
Changes from Baseline in Activities of Daily Living (ADL)
Measured: Month 1, Month 2, , Month 3, , Month 6
Secondary outcomes (1)
Changes from Baseline in the symptom scales from Chinese medicine's perspective
Measured: Month 1, Month 2, , Month 3, , Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2011 (estimated)
- Study startMar 2002
- Primary completionOct 2002
- Study completionOct 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular DementiaStudies 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
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sinphar Pharmaceutical Co., Ltd
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mingjun Yang, Study chair, Affiliated Hospital of Chengdu University of Traditional Chinese Medicines
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01475578
- Sponsor's protocol ID
- 2001ZL272
- Status last verified
- Nov 2011
- First submitted
- 14 Nov 2011
- Last updated
- 21 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Double-Dummy, Active-Controlled, Parallel, Comparative, Multicenter, Phase II Study to Evaluate the Efficacy and Safety of STA-1 Capsule in Patients With Vascular Dementia (Marrow-Sea Deficiency)
- ClinicalTrials.gov ID
- NCT01475578
- Acronym / sponsor ID
- 2001ZL272
- Conditions
- Vascular Dementia
- Keywords
- Vascular Dementia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Sinphar Pharmaceutical Co., LtdUniversity, hospital or other
- Study start
- Mar 2002
- Primary completion
- Oct 2002 (actual)
- Study completion
- Oct 2002 (actual)
- First posted
- 21 Nov 2011 (estimated)
- 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.
The objectives of this phase II study of STA-1 capsule was to make preliminary evaluation on clinical efficacy and safety of STA-1 capsule in order that based on the dosage and study structure planned in this project, the dosage and study structure of phase III study can be confirmed.
Detailed description
This phase II clinical trial was planned to be in double-blind, double-dummy, active-controlled, parallel, comparative, multicenter design. Two hundred and 40 eligible subjects were planned to be recruited by 5 study centers. The treatment period planned in the protocol was 3 months with 5 study visits including Randomization visit (Day 0), three post-treatment visits (1 and 2 months after Randomization visit and Final visit) and 1 follow-up visit made at 6 month after Randomization visit.
After subjects recruited by this study having read and singed the ICF, they were arranged to be collected information of demographics, medical history, allergy history, medication history, and concomitant medication. Laboratory and physical examination including vital signs were performed, and Hachinski Ischemia Score (HIS), Mini-Mental Status Examination (MMSE), and Classification of Marrow-Sea deficiency were evaluated to ensure subject's eligibility to enter this study. After the subjects were confirmed eligible, they were randomly assigned to either STA-1 or Ergoloid Mesylates group. Blessed-Roth Behavior Scale (BBS) and Activities of Daily Living (ADL) Scale were measured after subjects were randomized. These subjects were then dispensed study medications for 1-month use.
The eligible subjects were requested to bring back unused study medication, if any, to study centers at 1, 2, and 3 months (Final visit) after the Randomization visit. At these visits, measurements of MMSE, BBS, ADL scales, and Classification of Marrow-Sea deficiency were collected. Information concomitant medications and AEs were also recorded. Physical and laboratory examinations were performed at Final visit. Each subject was dispensed with study medications for his/her subsequent treatment period at month-1 and -2 visits. Unused study medications were collected with drug accountability documented. Subjects were dismissed from the study at the Final visit.
Subjects were measured MMSE, BBS, and ADL scales at 6 months after the Randomization visit if they were available for follow-up evaluations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STA-1 | Experimental | Drug: STA-1STA-1 capsule (Cistanche tubulosa), 2 capsules/time, 3 times/day, orally Dummy Ergoloid Mesylates tablet (Placebo), 2 tablets/time, 3 times/day, orally |
| Ergoloid Mesylates | Active comparator | Drug: Ergoloid Mesylates tabletErgoloid Mesylates tablet, 2 tablets/time, 3 times/day, orally before meal Dummy STA-1 capsule (Placebo), 2 capsules/time, 3 times/day, orally |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Meeting criteria of dementia according to Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV)
- Meeting criteria of vascular dementia according to National Institute of Neurological Disorders and Stroke-Association Internationale pour la Recherche et l'Enseignement en Neurosciences (NINDS/AIREN)
- With Mini-Mental State Examination (MMSE score) ≦17 (illiteracy); ≦20 (elementary school); ≦24 (high school or above)
- With Hachinski's ischemic score (HIS) ≧7
- With marrow-sea deficiency from Chinese medicine's perspective
Key exclusion criteria (19 listed)
- Dementia besides study indication based on DSM-IV and NINDS/AIREN, e.g. Alzheimer's disease, Lwey body disease, etc.
- With HIS < 7
- Diagnosed significant depression based on DSM-IV with score >8 or with other mental diseases/disorders
- With cognitive dysfunction caused by head impairment
- With medical history of epilepsy, encephalitis, or any other diseases that may result in dementia, e.g. Parkinson's disease, Huntington disease, Pick disease, etc. Patients with epilepsy attacked occasionally should be examined at the first visit by electroencephalography (EEG) and should be excluded from this study if by the test results are positive.
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 |
|---|---|---|
| STA-1STA-1 capsule (manufactured by Sinphar Tian-Li (Hangzhou) Pharm. Co., Ltd.; Batch number: 020121), 2 capsules/time, 3 times/day, orally | Drug | STA-1 |
| Ergoloid Mesylates tabletErgoloid Mesylates tablet (manufactured by Tianjin Huajin Pharmaceutical Factory; Batch number: 011230), 2 tablets/time, 3 times/day, orally before meal | Drug | Ergoloid Mesylates |
Primary outcome
Changes from Baseline in Mini-Mental State Examination (MMSE)
Time frame: Month 1, Month 2, , Month 3, , Month 6
MMSE were used to evaluate subject's change in orientation, attention and calculation, immediate recall and delayed memory, and language ability before and after treatment.
Changes from Baseline in Blessed-Roth Behavior Scale (BBS)
Time frame: Month 1, Month 2, , Month 3, , Month 6
Changes from Baseline in Activities of Daily Living (ADL)
Time frame: Month 1, Month 2, , Month 3, , Month 6
1 secondary outcome
Changes from Baseline in the symptom scales from Chinese medicine's perspective
Time frame: Month 1, Month 2, , Month 3, , Month 6
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 Nov 2011.
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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.
Mingjun Yang study chair
Affiliated Hospital of Chengdu University of Traditional Chinese Medicines
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing STA-1 and Ergoloid Mesylates tablet in people with Vascular Dementia, run by Sinphar Pharmaceutical Co., Ltd at 5 sites 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 10 inclusion and 19 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 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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. 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Changes from Baseline in Mini-Mental State Examination (MMSE) (time frame: Month 1, Month 2, , Month 3, , Month 6). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Nov 2011.