Clinical trial NCT03838952: The Efficacy of Traditional Chinese Herbal Medicine for Dementia
Official title: The Efficacy of Traditional Chinese Herbal Medicine for Dementia: a Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dementia
Alzheimer Disease
Keywords: Chinese Herbal Medicine
Herbal treatment
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2019-02-12
Enrollment: 20
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Changes of Mini-Mental State Examination(MMSE)
timeFrame: week 0, 12, 16
measure: Changes of Instrumental Activities of Daily Living (IADL)
timeFrame: week 0, 12, 16
measure: Changes of Neuropsychiatric Inventory(NPI-Q)
timeFrame: week 0, 12, 16
measure: Changes of Geriatric Depression Scale (GDS)
timeFrame: week 0, 12, 16
Secondary outcomes:
measure: Blood test (AST/ALT/Serum Creatinine)
timeFrame: week 0, 16
measure: Changes of Quality of Life-Alzheimer's Disease (QOL-AD)
timeFrame: week 0, 12, 16
measure: Changes of Constitution in Chinese Medicine Questionnaire
timeFrame: week 0, 12, 16
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
References: