The Efficacy of Traditional Chinese Herbal Medicine for Dementia

Alzheimer Disease Clinical Trial

Official title:

The Efficacy of Traditional Chinese Herbal Medicine for Dementia: a Pilot Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03838952
• Other study ID #: 2018-07-021B
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 11, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: February 2019
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: Fang-Pey Chen, MD
• Phone: +886-2-2875-7453
• Email: fpchen[@]vghtpe.gov.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The Clinical trial is a pilot study for treatment of Alzheimer dementia by traditional Chinese herbal medicine(TCM).

Description:

Dementia is a chronic, progressive neurodegenerative syndrome, characterized by an abroad category of non-reversible impairment in cerebral function, making a long-term and gradually decrease in the ability to mental cognitive tasks and performance of daily activities.

The World Health Organization says that 47.5 million people around the world are living with dementia. Alzheimer's disease is the most common type of dementia. Alzheimer's disease is often getting worse with time, affecting memory, language, and thought.

According to the record from Ministry of Health and welfare in Taiwan. The population over 65 year-old is more than 3.36 million. It is estimated that there are more than 250,000 people with mental disabilities, and nearly 600,000 people with mild cognitive impairment (MCI). Alzheimer's disease is accounting for 60-70%, the most common type of dementia. With the aging of population, experts predict that the number of patients suffering from Alzheimer's disease will be up to 800,000.

In 2016, a study based on the health insurance database in Taiwan showed that 78.2% of patients will take Chinese medical treatment, such as herbal medicine, acupuncture or traumatology medical therapy like massage after diagnosed as Alzheimer's disease during 1997-2008.

The clinical trial is a pilot study. The main purpose of this study is to evaluate the efficacy of traditional Chinese herbal medicine(TCM) of Alzheimer's dementia. The participants diagnosed as Alzheimer's dementia will be given Traditional Chinese herbal medicine powder, each pack included of Jia Wei Xiao Yao San granule(5 gm), Gou Teng granule (1.1 gm),and Ba Ji Tian (1.1 gm), 2 times per day for 12 weeks. The participants will be assessed by the MMSE, IADL, NPI-Q, GDS, QOL-AD, CCMQ, which will be conducted at baseline, 0weeks, 12weeks, and follow-up (16 weeks). To see if the traditional Chinese herbal medicine can improve the symptoms of Alzheimer's dementia or its related symptoms.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

1. diagnosis of mild to moderate Alzheimer dementia;

2. aged over 65 years old in both gender;

3. MMSE score between 14 and 26;

4. adequate vision and hearing ability to complete all study tests;

5. with a stable caregiver.

Exclusion Criteria:

1. a medical history of other dementia types, like Frontotemporal dementia, Dementia with Lewy Bodies, Vascular Dementia, and mixed type, et al;

2. known of other neurological diseases, cranial nervous system cancer

3. severe liver or kidney dysfunction (alanine aminotransferase>200 IU/L, aspartate transaminase>200 IU/L or serum creatinine >2.5 mg/dl);

4. severe cardiovascular disease (heart failure, coronary heart disease)

Related Conditions & MeSH terms

• Alzheimer Disease
• Dementia

Intervention

Drug:
• Herbal medicine
Each pack: Jia Wei Xiao Yao San granule(5 gm), Gou Teng granule (1.1 gm),and Ba Ji Tian (1.1 gm), 2 times per day for 12 weeks.

Locations

Country	Name	City	State
Taiwan	Taipei Veterans General Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of Mini-Mental State Examination(MMSE)	Global cognition will be assessed by the MMSE,which will be conducted at baseline, 0weeks, 12weeks, and follow-up (16 weeks).	week 0, 12, 16
Primary	Changes of Instrumental Activities of Daily Living (IADL)	The instrumental activities of daily living (IADL) contains 8 items ,such as shopping, cooking, doing laundry, handling finances, using telephone, mode of transportation, responsibility for own medication and housekeeping.The IADL wil be conducted baseline, 12weeks, and follow-up (16 weeks)	week 0, 12, 16
Primary	Changes of Neuropsychiatric Inventory(NPI-Q)	The Neuropsychiatric Inventory Questionnaire (NPI-Q) is an informant-based instrument that measures the presence and severity of 12 Neuropsychiatric Symptoms (NPS) in patients with dementia, as well as informant distress. The NPI-Q will be conducted at baseline, 12 weeks, and follow-up (16 weeks).	week 0, 12, 16
Primary	Changes of Geriatric Depression Scale (GDS)	The Geriatric Depression Scale (GDS) is a 30-item self-report assessment used to identify depression in the elderly, which will be conducted at baseline, 12weeks, and follow-up (16 weeks).	week 0, 12, 16
Secondary	Blood test (AST/ALT/Serum Creatinine)	Check liver and kidney function through blood test at baseline, and follow-up (16 weeks).	week 0, 16
Secondary	Changes of Quality of Life-Alzheimer's Disease (QOL-AD)	The Quality of Life-Alzheimer's Disease (QOL-AD) has 13-items covering physical health, energy, mood, living situations, memory, family, marriage, friends, chores, fun, money, self and life as a whole. The QOL-AD uses straightforward language for simplicity, which will be conducted at baseline, 12 weeks, and follow-up (16 weeks).	week 0, 12, 16
Secondary	Changes of Constitution in Chinese Medicine Questionnaire	The Constitution in Chinese Medicine Questionnaire (CCMQ) consists of 60 items to classify a person into one or more of nine Body constitution(BC) types: gentleness (8 Items), Qi-deficiency (8 Items), Yang-deficiency (7 Items), Yin-deficiency (8 Items), phlegm-wetness (8 Items), wetness-heat (6 Items), blood-stasis (7 Items), Qi-depression (7 Items), and special diathesis (7 Items). Coexistence of multiple imbalanced BC types was possible which is consistent with the TCM theories. The scoring algorithm proposed in the original CCMQ was adopted in this study. A higher score in the CCMQ BC scale indicates a higher likelihood of the specific BC type, and a score of 30 is set as threshold for case definition. The CCMQ will be conducted at baseline, 12 weeks, and follow-up (16 weeks).	week 0, 12, 16