The Efficacy of Traditional Chinese Herbal Medicine for Dementia

NCT ID: NCT03838952

Last Updated: 2019-02-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-11
• Study Completion Date: 2020-12-31

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.

Conditions

Dementia; Alzheimer Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Chinese herbal medicine group

drug for the subjects

Group Type: EXPERIMENTAL

Herbal medicine

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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)

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Taipei Veterans General Hospital

Taipei, , Taiwan

Countries

Taiwan

Central Contacts

Fang-Pey Chen, MD

Role: CONTACT

fpchen@vghtpe.gov.tw

+886-2-2875-7453

Pei-Wen Wu, MD

Role: CONTACT

tcmpww@gmail.com

+886-2-2875-7453

Facility Contacts

Fang-Pey Chen, MD

Role: primary

Other Identifiers

2018-07-021B

Identifier Type: -

Identifier Source: org_study_id