SchizophreniaPhase 1NCT04252131
Therapeutic Effect of Cassia Seed in Obesity of Patients With Schizophrenia
A Phase 1 study testing cassia seed tablet in people with Schizophrenia, run by Calo Psychiatric Center at 1 site in Taiwan.
Trial summary
Schizophrenia patients with anti-psychotics have decreased psychiatric symptoms, but have increased the generation of overweight or obesity. There is correlation between obesity, diabetes mellitus, metabolic syndrome, hypertension, hyperlipidemia and cardiovascular disorders. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- cassia seed tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 1 siteTaiwan
- Study dates
- 17 May 2018to 31 Oct 2019
- Phase
- 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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 18 to 65 years
- diagnosed as schizophrenia at least more 6 months
- no major systemic illnesses based on physical examinations and laboratory test results
- BMI >= 24, WC >= 80 cm in female, WC >= 90 cm in male
Who cannot join
- participants were pregnant and lactating women
- allergy to Cassia
- SGOT or SGPT more than 2 times normal level
- BUN or creatinine more than normal level
- Fasting blood glucose (serum) > 140 mg/dL, systolic blood pressure > 180 mmHg, diastolic blood pressure > 110 mmHg, serum triglyceride > 400 mg/dL
Trial locations and contacts
1 site in 1 country.
About this study
Schizophrenia patients with anti-psychotics have decreased psychiatric symptoms, but have increased the generation of overweight or obesity. There is correlation between obesity, diabetes mellitus, metabolic syndrome, hypertension, hyperlipidemia and cardiovascular disorders. Cassia seed is one of traditional Chinese herbs, that can decline blood lipedema effect. Therefore, the purpose of the present study was to design a randomized, double blind, control group study to assess the therapeutic effect of Cassia seed in schizophrenia patients with obesity.
Read the detailed description
Total of 92 schizophrenia patients with obesity will be enrolled and divided randomly into: 1) case group, received oral administration of Cassia seed (3.0g), once/day, 12 weeks; 2) control group, received oral administration of Cassia seed placebo (3.0g), once/day (90% of starch and 10% of cassia obtusifolia), 12 weeks. The primary outcome included the changes of body mass index (BMI), waist circumferences (WC); secondary outcome measured included the changes of hemoglobin A1c (HbA1c), total cholesterol, triglyceride, high density lipoprotein, low density lipoprotein, CRP (C-Reactive protein), IL-6, systolic blood pressure, diastolic blood pressure, and meridian energy.
- Conditions
- Schizophrenia
- Being tested
- cassia seed tablet
- Keywords
- Schizophrenia, Cassia seed, obesity, Therapeutic effect assessment, clinical trial
- Medical subject headings
- Schizophrenia, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cassia seed tabletDrug
Also called cassia obtusifolia
traditional Chinese herbs
| Study group | Role | What they receive |
|---|---|---|
| Cassia seed | Experimental | oral administration of Cassia seed (3.0g), once/day for 12 weeks Receives: Drug: cassia seed tablet |
| Cassia seed placebo | Placebo comparator | oral administration of Cassia seed placebo (3.0g), once/day (90% of starch and 10% of cassia obtusifolia) for 12 weeks Receives: Drug: cassia seed tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
physiological parameter for measuring Height and weight
the parameter of BMI in kg/m^2 for exploring the changes of body mass index (BMI) after cassia obtusifolia treatment
Measured: 12 weeks
sphygmomanometer
the parameter of systolic blood pressure and diastolic blood pressure after cassia obtusifolia treatment
Measured: 12 weeks
Secondary outcomes (2)
Blood analyzer
the concentration of lipid profile, including total cholesterol, triglyceride, high denisty lipoprotein and low density lipoprotein after cassia obtusifolia treatment.
Measured: 12 weeks
Meridian energy skin conductivity assessment using amperometer (0-200uA)
the parameter of meridian energy after cassia obtusifolia treatment
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start17 May 2018
- Primary completion31 Oct 2019
- Study completion31 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Total of 92 schizophrenia patients with obesity was divided randomly into: 1) control group, received oral administration of Cassia seed placebo (3.0g), once/day for 12 weeks continuously; 2) treatment group, received oral administration of Cassia seed (3.0g), once/day for 12 weeks continuously.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Calo Psychiatric Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, For-Wey Lung, Calo Psychiatric Center
- Investigators
- For-Wey Lung, MD, ScD, Principal investigator, Calo Psychiatric Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04252131
- Sponsor's protocol ID
- 106-046
- Status last verified
- Jan 2020
- First submitted
- 26 Dec 2019
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Effect of Cassia Seed in Obesity of Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT04252131
- Acronym / sponsor ID
- 106-046
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Cassia seed, obesity, Therapeutic effect assessment, clinical trial
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Calo Psychiatric CenterUniversity, hospital or other
- Study start
- 17 May 2018 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 31 Oct 2019 (actual)
- First posted
- 5 Feb 2020 (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.
Schizophrenia patients with anti-psychotics have decreased psychiatric symptoms, but have increased the generation of overweight or obesity. There is correlation between obesity, diabetes mellitus, metabolic syndrome, hypertension, hyperlipidemia and cardiovascular disorders. Cassia seed is one of traditional Chinese herbs, that can decline blood lipedema effect. Therefore, the purpose of the present study was to design a randomized, double blind, control group study to assess the therapeutic effect of Cassia seed in schizophrenia patients with obesity.
Detailed description
Total of 92 schizophrenia patients with obesity will be enrolled and divided randomly into: 1) case group, received oral administration of Cassia seed (3.0g), once/day, 12 weeks; 2) control group, received oral administration of Cassia seed placebo (3.0g), once/day (90% of starch and 10% of cassia obtusifolia), 12 weeks. The primary outcome included the changes of body mass index (BMI), waist circumferences (WC); secondary outcome measured included the changes of hemoglobin A1c (HbA1c), total cholesterol, triglyceride, high density lipoprotein, low density lipoprotein, CRP (C-Reactive protein), IL-6, systolic blood pressure, diastolic blood pressure, and meridian energy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Total of 92 schizophrenia patients with obesity was divided randomly into: 1) control group, received oral administration of Cassia seed placebo (3.0g), once/day for 12 weeks continuously; 2) treatment group, received oral administration of Cassia seed (3.0g), once/day for 12 weeks continuously.
| Arm | Type | Receives |
|---|---|---|
| Cassia seed | Experimental | Drug: cassia seed tabletoral administration of Cassia seed (3.0g), once/day for 12 weeks |
| Cassia seed placebo | Placebo comparator | Drug: cassia seed tabletoral administration of Cassia seed placebo (3.0g), once/day (90% of starch and 10% of cassia obtusifolia) for 12 weeks |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age 18 to 65 years
- diagnosed as schizophrenia at least more 6 months
- no major systemic illnesses based on physical examinations and laboratory test results
- BMI >= 24, WC >= 80 cm in female, WC >= 90 cm in male
Key exclusion criteria (5 listed)
- participants were pregnant and lactating women
- allergy to Cassia
- SGOT or SGPT more than 2 times normal level
- BUN or creatinine more than normal level
- Fasting blood glucose (serum) > 140 mg/dL, systolic blood pressure > 180 mmHg, diastolic blood pressure > 110 mmHg, serum triglyceride > 400 mg/dL
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 |
|---|---|---|
| cassia seed tabletAlso: cassia obtusifoliatraditional Chinese herbs | Drug | Cassia seed, Cassia seed placebo |
Primary outcome
physiological parameter for measuring Height and weight
Time frame: 12 weeks
the parameter of BMI in kg/m^2 for exploring the changes of body mass index (BMI) after cassia obtusifolia treatment
sphygmomanometer
Time frame: 12 weeks
the parameter of systolic blood pressure and diastolic blood pressure after cassia obtusifolia treatment
2 secondary outcomes
Blood analyzer
Time frame: 12 weeks
Meridian energy skin conductivity assessment using amperometer (0-200uA)
Time frame: 12 weeks
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 5 Feb 2020.
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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.
For-Wey Lung, MD, ScD principal investigator
Calo Psychiatric Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing cassia seed tablet in people with Schizophrenia, run by Calo Psychiatric Center at 1 site in Taiwan.
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 4 inclusion and 5 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 5 Feb 2020. 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 Taiwan. 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
physiological parameter for measuring Height and weight (time frame: 12 weeks). 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?
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 5 Feb 2020.