Protective Qi Deficiency syndrome
Conditions
Interventions
Test group:Proglucamune
Control group:Placebo
Sponsors
Beijing University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Persons who meet the diagnostic criteria of Protective Qi deficiency syndrome; 2. Male or females aged 18 to 65 years (inclusive) without regard to race or ethnic background; 3. Persons willing to participate in this study and sign the informed consent; 4. Persons willing to follow all study instructions and consume the assigned investigational product for 12 weeks; 5. Not currently taking a beta-glucan containing supplement or any other supplement that might interfere with the study design; 6. Ability to swallow tablets and pills.
Exclusion criteria
Exclusion criteria: 1. Persons with other diseases that may affect Protective Qi deficiency syndrome, especially those with obvious other viscera deficiency syndrome; 2. Significant acute or chronic illness or other medical conditions that will prevent or interfere with giving an informed consent (excluding patients with well controlled hypertension, coronary heart disease, diabetes, hyperlipidemia, etc); 3. Scheduling difficulties or lack of transportation that will prevent or interfere with their ability to attend all of the necessary study visits; 4. Persons medically diagnosed with depression or anxiety disorders; 5. Persons with a history of alcohol abuse or other substance abuse within the previous 2 years. 6. Females who are attempting to become pregnant, pregnant, lactating or who have given birth within 1 year; 7. Persons who have had a medical surgery in the past 4 weeks or have scheduled a surgery during the study period; 8. Persons currently enrolled in a clinical trial, or who have completed a clinical trial within the last 4 weeks; 9. Allergies to mushrooms or other fungi; 10. Significant problems with constipation or diarrhea; 11. A lifestyle or schedule incompatible with the study protocol; 12. Persons who are allergic to yeast products, have autoimmune disease/ an immune disorder, or take antidepressants, blood thinners (anticoagulants, acetylsalicylic acid), or immunosuppressant medication.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Protective Qi Deficiency Evaluation Scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| upper respiratory tract infection events;Fatigue Self Assessment Scale;Mental Health Scale;Sleep quality scale;Tongue and pulse; | — |
Countries
China
Contacts
Public ContactYang Jiao
The Second Clinical Medical College of Beijing University of Chinese Medicine
Outcome results
None listed