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The Efficacy of Traditional Chinese Herbal Medicine for Dementia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03838952
Recruitment Status : Not yet recruiting
First Posted : February 12, 2019
Last Update Posted : February 12, 2019
Sponsor:
Information provided by (Responsible Party):
Taipei Veterans General Hospital, Taiwan

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

Condition or disease Intervention/treatment Phase
Dementia Alzheimer Disease Drug: Herbal medicine Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Efficacy of Traditional Chinese Herbal Medicine for Dementia: a Pilot Study
Estimated Study Start Date : February 11, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2020


Arm Intervention/treatment
Experimental: Chinese herbal medicine group
drug for the subjects
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.




Primary Outcome Measures :
  1. Changes of Mini-Mental State Examination(MMSE) [ Time Frame: week 0, 12, 16 ]
    Global cognition will be assessed by the MMSE,which will be conducted at baseline, 0weeks, 12weeks, and follow-up (16 weeks).

  2. Changes of Instrumental Activities of Daily Living (IADL) [ Time Frame: week 0, 12, 16 ]
    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)

  3. Changes of Neuropsychiatric Inventory(NPI-Q) [ Time Frame: week 0, 12, 16 ]
    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).

  4. Changes of Geriatric Depression Scale (GDS) [ Time Frame: week 0, 12, 16 ]
    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).


Secondary Outcome Measures :
  1. Blood test (AST/ALT/Serum Creatinine) [ Time Frame: week 0, 16 ]
    Check liver and kidney function through blood test at baseline, and follow-up (16 weeks).

  2. Changes of Quality of Life-Alzheimer's Disease (QOL-AD) [ Time Frame: week 0, 12, 16 ]
    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).

  3. Changes of Constitution in Chinese Medicine Questionnaire [ Time Frame: week 0, 12, 16 ]
    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).



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03838952


Contacts
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Contact: Fang-Pey Chen, MD +886-2-2875-7453 fpchen@vghtpe.gov.tw
Contact: Pei-Wen Wu, MD +886-2-2875-7453 tcmpww@gmail.com

Locations
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Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan, 112
Contact: Fang-Pey Chen, MD         
Sponsors and Collaborators
Taipei Veterans General Hospital, Taiwan

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Responsible Party: Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier: NCT03838952    
Other Study ID Numbers: 2018-07-021B
First Posted: February 12, 2019    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Taipei Veterans General Hospital, Taiwan:
Chinese Herbal Medicine
Herbal treatment
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders