Ensure the Legality and Compliance of the Testing ProcessEarly Phase 1NCT06393413
To Explore the Therapeutic Potential of Jiedu Yizhi Formula for Alzheimer 's Disease
A Early Phase 1 study testing Jiedu Yizhi Formula and Donepezil Hydrochloride Tablets in people with Ensure the Legality and Compliance of the Testing Process, run by Changchun University of Chinese Medicine at 1 site in China.
Trial summary
AD patients who met the inclusion criteria in the encephalopathy clinic and treatment area of the Third Clinical Hospital Affiliated to Changchun University of Traditional Chinese Medicine from December 2022 to December 2023 were collected and randomly divided into traditional Chinese medicine experimental group and… Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Ensure the Legality and Compliance of the Testing Process
- What is being tested?
- Jiedu Yizhi Formula and Donepezil Hydrochloride Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2022to 1 Apr 2024
- 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 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meet the above NIA-AA AD diagnostic criteria; (2) Meets the diagnostic criteria for traditional Chinese medicine syndromes mentioned above; (3) Age range from 55 to 85 years old, regardless of gender; (4) MMSE scale scores range from 10 to 26 points; (5) The CDR scale scores 1 or 2 points; (6) The HAMD scale score is less than 8 points; (7) HAMA scale score below 7 points; (8) At least 4 elements of kidney deficiency, spleen deficiency, marrow deficiency, blood stasis, and phlegm turbidity syndrome in the PES-D/11 scale score are valid, and may be accompanied by toxic excess syndrome elements (the sum of scores greater than or equal to 7 points is considered valid); (9) HIS scale score below 5 points; (10) Family members agree and sign an informed consent form.
Who cannot join
- Severe dementia patients; (2) Other types of dementia such as vascular dementia, frontotemporal lobe dementia, Lewy body dementia, mixed dementia, as well as secondary dementia caused by infection, poisoning, metabolism, tumors, and other reasons; (3) There are other diseases that may cause cognitive impairment; (4) Patients who cannot fully cooperate with the assessment; (5) Patients with unstable vital signs and critical condition; (6) Patients with concomitant psychiatric disorders; (7) Patients with scores of less than 7 on the PES-D/11 scale for spleen deficiency, kidney deficiency, marrow deficiency, blood stasis, and phlegm turbidity; (8) Patients with long-term alcohol or drug abuse that affects efficacy evaluation; (9) Patients who have experienced serious adverse reactions or allergies to the drugs in this study due to previous use of traditional Chinese medicine.
Trial locations and contacts
1 site in 1 country.
China1 site
Changchun University of Traditional Chinese Medicine
Changchun, Jilin, 130117
About this study
Official title: Changchun University of Chinese Medicine
AD patients who met the inclusion criteria in the encephalopathy clinic and treatment area of the Third Clinical Hospital Affiliated to Changchun University of Traditional Chinese Medicine from December 2022 to December 2023 were collected and randomly divided into traditional Chinese medicine experimental group and western medicine control group. The experimental group was treated with Jiedu Yizhi Formula, and the control group was treated with Donepezil Hydrochloride Tablets ( trade name : Aricept ). The two groups were given AD cognitive behavior training and health education at the same time. The course of treatment was 24 weeks. The Western medicine scale was measured before treatment, 12 weeks after treatment and 24 weeks after treatment to evaluate the effect of drugs on cognitive function and daily living ability.
Read the detailed description
From December 2022 to December 2023, we conducted a prospective randomized controlled single center study on AD patients exhibiting mild to moderate spleen and kidney deficiency, phlegm turbidity, and obstruction of the orifices. These patients were admitted to the outpatient department and treatment area of the Brain Disease Department at the Third Affiliated Clinical Hospital of Changchun University of Chinese Medicine. Following a comprehensive evaluation, the diagnosis of AD was confirmed. This study was conducted in accordance with the principles of the Helsinki Declaration. The practitioner declares that all procedures follow medical regulations and this study was evaluated and approved by the Ethics Committee of the Third Affiliated Clinical Hospital of Changchun University of Traditional Chinese Medicine. The study was designed based on the observation reports presented in the randomized controlled study of strengthening epidemiology (STROBE).The traditional Chinese medicine treatment group received modified Jiedu Yizhi Formula therapy, with no more than 3 flavors, customized based on syndrome differentiation. The herbal composition included 10g of Coptis chinensis Franch (Huanglian, Ranunculaceae, rhizome), 20g of Alpinia oxyphylla Miq.(Yizhiren, Zingiberaceae, fructus), 10g of Chinemys reevesii(Guibanjiao), 10g of Rheum webbianum (Jiu Dahuang, rhizome), 10g of Cornus officinalis (Shanzhuyu, Cornaceae, fructus), 10g of Pheretima aspergillum (Dilong), and 10g of Oreocome striata (Chuanxiong, Apiaceae, rhizome). 300ml of water decoction juice was prepared from each pair of herbs, and 100ml was taken daily after breakfast and dinner. The Western medicine control group, on the other hand, was administered donepezil hydrochloride (Anlishen 5mg/tablet, from Weicai China Pharmaceutical Co., Ltd.) orally before bedtime at a dosage of 5mg per day. Subsequently, the dosage was increased to 10mg per day for maintenance therapy, leading to a total of 24 weeks of continuous treatment. Additionally, both patient groups were provided guidance on actively addressing and managing various risk factors associated with Alzheimer's disease, in conjunction with cognitive behavioral training.
- Being tested
- Jiedu Yizhi Formula, Donepezil Hydrochloride Tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jiedu Yizhi FormulaDrug
Observation after 24 weeks of drug treatment
Donepezil Hydrochloride TabletsDrug
Donepezil Hydrochloride Tablets
| Study group | Role | What they receive |
|---|---|---|
| Jiedu Yizhi Formula | Experimental | The traditional Chinese medicine treatment group received modified Jiedu Yizhi Formula therapy, with no more than 3 flavors, customized based on syndrome differentiation. The herbal composition included 10g of Coptis chinensis Franch (Huanglian, Ranunculaceae, rhizome), 20g of Alpinia oxyphylla Miq.(Yizhiren, Zingiberaceae, fructus), 10g of Chinemys reevesii(Guibanjiao), 10g of Rheum webbianum (Jiu Dahuang, rhizome), 10g of Cornus officinalis (Shanzhuyu, Cornaceae, fructus), 10g of Pheretima aspergillum (Dilong), and 10g of Oreocome striata (Chuanxiong, Apiaceae, rhizome). 300ml of water decoction juice was prepared from each pair of herbs, and 100ml was taken daily after breakfast and dinner. Receives: Drug: Jiedu Yizhi Formula |
| Donepezil Hydrochloride Tablets | Sham comparator | The Western medicine control group, on the other hand, was administered donepezil hydrochloride (Anlishen 5mg/tablet, from Weicai China Pharmaceutical Co., Ltd.) orally before bedtime at a dosage of 5mg per day. After 4 weeks of treatment, clinical reactions were assessed, and no significant abnormal clinical reactions were observed. Subsequently, the dosage was increased to 10mg per day for maintenance therapy, leading to a total of 24 weeks of continuous treatment. Additionally, both patient groups were provided guidance on actively addressing and managing various risk factors associated with Alzheimer's disease, in conjunction with cognitive behavioral training. Receives: Drug: Donepezil Hydrochloride Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini-mental State Examination(MMSE)
The most widely used cognitive screening tool in the world today, the MMSE was created by Folstein et al. in 1975. It is frequently used to measure endpoint outcomes, evaluate cognitive levels, and screen for cognitive impairment. 30 points is the highest score, and 0 points is the lowest. The better the cognitive function, the higher the score.
Measured: 24 weeks
Montreal Cognitive Assessment (MoCA)
Professor Nasreddine and colleagues created MoCA in 2004. Recall, naming, abstraction, language, attention, visual spatial and executive abilities, and directional abilities are among the eight areas on the scale that assess cognitive performance. Higher scores indicate stronger cognitive function. The scores range from 0 to 30.
Measured: 24 weeks
Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-cog）
The 12-item ADAS cog is used to evaluate the degree of memory, language, and other cognitive impairments in people with Alzheimer's disease. Of them, four evaluate language, five evaluate memory and direction, two evaluate practical competence, and one evaluate focus and attention. The more severe the cognitive impairment, the higher the score on the ADAS log, which ranges from 0 to 70 points. The better the therapeutic impact, the lower the score after taking medication.
Measured: 24 weeks
Clinical dementia rating(CDR)
CDR (Clinical Dementia Rating) is a standard for evaluating the degree of dementia, which includes a series of cognitive function assessments, including memory, attention, understanding, sense of direction, computational ability, etc. The evaluation results include 0 points, 0.5 points, 1 point, 2 points, 3 points, 0 points indicating normal, and 0.5 points indicating mild dementia,
1 point represents moderate dementia, 2 points represents severe dementia, and 3 points represents terminal dementia.
Measured: 24 weeks
Secondary outcomes (2)
Activity of daily living（ ADL ）
Activity of daily life refers to the necessary activities that a person engages in every day to meet their daily needs, including eating, dressing, washing, bathing, toileting, dressing, etc. Functional movements include turning over, sitting up from bed, transferring, walking, driving a wheelchair, going up and down stairs, etc. The score ranges from 0 to 100 points, and the higher the score, the stronger the daily living ability.
Measured: 24 weeks
Hamilton Depression Stable （HAMD ）
Evaluate mental state using the HAMD scale.During the diagnosis and treatment process, it was found that many AD patients are accompanied by varying degrees of depression, which will also affect the improvement of their cognitive function. In terms of efficacy evaluation indicators, in addition to evaluating cognitive function scales, HAMD should also be included in the observation indicators. The score range for each scoring item is 0-4 points, with a total score of 0-76 points. When scoring, the doctor or evaluator needs to select the scoring item that best matches the symptoms of the evaluated person based on their actual situation, and give corresponding scores. The higher the score, the more severe the depressive symptoms are.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2024
- Study start1 Dec 2022
- Primary completion1 Dec 2023
- Study completion1 Apr 2024
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 Ensure the Legality and Compliance of the Testing ProcessStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changchun University of Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yunqiang Li, Changchun University of Chinese Medicine
- Investigators
- Wei Zhang, Dr., Study director, Affiliated Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06393413
- Sponsor's protocol ID
- CZDSFYLL2023-0010-01
- Status last verified
- Apr 2024
- First submitted
- 25 Apr 2024
- Last updated
- 2 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Li YQ, Chen DX, Zhu XT, Li W, Wu JL, Fang LM, Li MQ. Therapeutic Potential of Jiedu Yizhi Formula for Alzheimer's Disease: A Randomized Controlled Trial. Chin J Integr Med. 2026 Jul 31. doi: 10.1007/s11655-026-3944-z. Online ahead of print.
PubMed 42536296
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changchun University of Chinese Medicine
- ClinicalTrials.gov ID
- NCT06393413
- Acronym / sponsor ID
- CZDSFYLL2023-0010-01
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Changchun University of Chinese MedicineUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 1 May 2024 (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.
AD patients who met the inclusion criteria in the encephalopathy clinic and treatment area of the Third Clinical Hospital Affiliated to Changchun University of Traditional Chinese Medicine from December 2022 to December 2023 were collected and randomly divided into traditional Chinese medicine experimental group and western medicine control group. The experimental group was treated with Jiedu Yizhi Formula, and the control group was treated with Donepezil Hydrochloride Tablets ( trade name : Aricept ). The two groups were given AD cognitive behavior training and health education at the same time. The course of treatment was 24 weeks. The Western medicine scale was measured before treatment, 12 weeks after treatment and 24 weeks after treatment to evaluate the effect of drugs on cognitive function and daily living ability.
Detailed description
From December 2022 to December 2023, we conducted a prospective randomized controlled single center study on AD patients exhibiting mild to moderate spleen and kidney deficiency, phlegm turbidity, and obstruction of the orifices. These patients were admitted to the outpatient department and treatment area of the Brain Disease Department at the Third Affiliated Clinical Hospital of Changchun University of Chinese Medicine. Following a comprehensive evaluation, the diagnosis of AD was confirmed. This study was conducted in accordance with the principles of the Helsinki Declaration. The practitioner declares that all procedures follow medical regulations and this study was evaluated and approved by the Ethics Committee of the Third Affiliated Clinical Hospital of Changchun University of Traditional Chinese Medicine. The study was designed based on the observation reports presented in the randomized controlled study of strengthening epidemiology (STROBE).The traditional Chinese medicine treatment group received modified Jiedu Yizhi Formula therapy, with no more than 3 flavors, customized based on syndrome differentiation. The herbal composition included 10g of Coptis chinensis Franch (Huanglian, Ranunculaceae, rhizome), 20g of Alpinia oxyphylla Miq.(Yizhiren, Zingiberaceae, fructus), 10g of Chinemys reevesii(Guibanjiao), 10g of Rheum webbianum (Jiu Dahuang, rhizome), 10g of Cornus officinalis (Shanzhuyu, Cornaceae, fructus), 10g of Pheretima aspergillum (Dilong), and 10g of Oreocome striata (Chuanxiong, Apiaceae, rhizome). 300ml of water decoction juice was prepared from each pair of herbs, and 100ml was taken daily after breakfast and dinner. The Western medicine control group, on the other hand, was administered donepezil hydrochloride (Anlishen 5mg/tablet, from Weicai China Pharmaceutical Co., Ltd.) orally before bedtime at a dosage of 5mg per day. Subsequently, the dosage was increased to 10mg per day for maintenance therapy, leading to a total of 24 weeks of continuous treatment. Additionally, both patient groups were provided guidance on actively addressing and managing various risk factors associated with Alzheimer's disease, in conjunction with cognitive behavioral training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Jiedu Yizhi Formula | Experimental | Drug: Jiedu Yizhi FormulaThe traditional Chinese medicine treatment group received modified Jiedu Yizhi Formula therapy, with no more than 3 flavors, customized based on syndrome differentiation. The herbal composition included 10g of Coptis chinensis Franch (Huanglian, Ranunculaceae, rhizome), 20g of Alpinia oxyphylla Miq.(Yizhiren, Zingiberaceae, fructus), 10g of Chinemys reevesii(Guibanjiao), 10g of Rheum webbianum (Jiu Dahuang, rhizome), 10g of Cornus officinalis (Shanzhuyu, Cornaceae, fructus), 10g of Pheretima aspergillum (Dilong), and 10g of Oreocome striata (Chuanxiong, Apiaceae, rhizome). 300ml of water decoction juice was prepared from each pair of herbs, and 100ml was taken daily after breakfast and dinner. |
| Donepezil Hydrochloride Tablets | Sham comparator | Drug: Donepezil Hydrochloride TabletsThe Western medicine control group, on the other hand, was administered donepezil hydrochloride (Anlishen 5mg/tablet, from Weicai China Pharmaceutical Co., Ltd.) orally before bedtime at a dosage of 5mg per day. After 4 weeks of treatment, clinical reactions were assessed, and no significant abnormal clinical reactions were observed. Subsequently, the dosage was increased to 10mg per day for maintenance therapy, leading to a total of 24 weeks of continuous treatment. Additionally, both patient groups were provided guidance on actively addressing and managing various risk factors associated with Alzheimer's disease, in conjunction with cognitive behavioral training. |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Meet the above NIA-AA AD diagnostic criteria; (2) Meets the diagnostic criteria for traditional Chinese medicine syndromes mentioned above; (3) Age range from 55 to 85 years old, regardless of gender; (4) MMSE scale scores range from 10 to 26 points; (5) The CDR scale scores 1 or 2 points; (6) The HAMD scale score is less than 8 points; (7) HAMA scale score below 7 points; (8) At least 4 elements of kidney deficiency, spleen deficiency, marrow deficiency, blood stasis, and phlegm turbidity syndrome in the PES-D/11 scale score are valid, and may be accompanied by toxic excess syndrome elements (the sum of scores greater than or equal to 7 points is considered valid); (9) HIS scale score below 5 points; (10) Family members agree and sign an informed consent form.
Key exclusion criteria (1 listed)
- Severe dementia patients; (2) Other types of dementia such as vascular dementia, frontotemporal lobe dementia, Lewy body dementia, mixed dementia, as well as secondary dementia caused by infection, poisoning, metabolism, tumors, and other reasons; (3) There are other diseases that may cause cognitive impairment; (4) Patients who cannot fully cooperate with the assessment; (5) Patients with unstable vital signs and critical condition; (6) Patients with concomitant psychiatric disorders; (7) Patients with scores of less than 7 on the PES-D/11 scale for spleen deficiency, kidney deficiency, marrow deficiency, blood stasis, and phlegm turbidity; (8) Patients with long-term alcohol or drug abuse that affects efficacy evaluation; (9) Patients who have experienced serious adverse reactions or allergies to the drugs in this study due to previous use of traditional Chinese medicine.
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 Yizhi FormulaObservation after 24 weeks of drug treatment | Drug | Jiedu Yizhi Formula |
| Donepezil Hydrochloride TabletsDonepezil Hydrochloride Tablets | Drug | Donepezil Hydrochloride Tablets |
Primary outcome
Mini-mental State Examination(MMSE)
Time frame: 24 weeks
The most widely used cognitive screening tool in the world today, the MMSE was created by Folstein et al. in 1975. It is frequently used to measure endpoint outcomes, evaluate cognitive levels, and screen for cognitive impairment. 30 points is the highest score, and 0 points is the lowest. The better the cognitive function, the higher the score.
Montreal Cognitive Assessment (MoCA)
Time frame: 24 weeks
Professor Nasreddine and colleagues created MoCA in 2004. Recall, naming, abstraction, language, attention, visual spatial and executive abilities, and directional abilities are among the eight areas on the scale that assess cognitive performance. Higher scores indicate stronger cognitive function. The scores range from 0 to 30.
Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-cog）
Time frame: 24 weeks
The 12-item ADAS cog is used to evaluate the degree of memory, language, and other cognitive impairments in people with Alzheimer's disease. Of them, four evaluate language, five evaluate memory and direction, two evaluate practical competence, and one evaluate focus and attention. The more severe the cognitive impairment, the higher the score on the ADAS log, which ranges from 0 to 70 points. The better the therapeutic impact, the lower the score after taking medication.
Clinical dementia rating(CDR)
Time frame: 24 weeks
CDR (Clinical Dementia Rating) is a standard for evaluating the degree of dementia, which includes a series of cognitive function assessments, including memory, attention, understanding, sense of direction, computational ability, etc. The evaluation results include 0 points, 0.5 points, 1 point, 2 points, 3 points, 0 points indicating normal, and 0.5 points indicating mild dementia, 1 point represents moderate dementia, 2 points represents severe dementia, and 3 points represents terminal dementia.
2 secondary outcomes
Activity of daily living（ ADL ）
Time frame: 24 weeks
Hamilton Depression Stable （HAMD ）
Time frame: 24 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 2 May 2024.
- Derived from this study: PubMed 42536296Li YQ, Chen DX, Zhu XT, Li W, Wu JL, Fang LM, Li MQ. Therapeutic Potential of Jiedu Yizhi Formula for Alzheimer's Disease: A Randomized Controlled Trial. Chin J Integr Med. 2026 Jul 31. doi: 10.1007/s11655-026-3944-z. Online ahead of print.
- Individual participant dataSharing planned: Yes
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.
Wei Zhang, Dr. study director
Affiliated 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 Yizhi Formula and Donepezil Hydrochloride Tablets in people with Ensure the Legality and Compliance of the Testing Process, run by Changchun University of Chinese Medicine 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 1 inclusion and 1 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 2 May 2024. 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?
Mini-mental State Examination(MMSE) (time frame: 24 weeks). The study lists 4 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 NCT06393413, 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 2 May 2024.