The Clinical Study on the Effect of Hyangsayukgunja-tang on the Spleen Qi deficiency

The Clinical Study on the Effect of Hyangsayukgunja-tang on the Spleen Qi deficiency - randomized, placebo-controlled, double-blinding, parallel clinical trial -

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0001428

Enrollment

Registered

2015-03-30

Start date

2015-03-11

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Test group(Hyangsayukgunja-tang) - Granule of Hansin-Hyangsayukgunja-tang (Hankookshinyak) 1pack(5g)/time, 3times/day, before or between the meal, for four weeks Control group(Placebo group) -

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Age over 18 and under 65 - BMI < 23kg/m2 - Having symptoms of fatigue, anorexia, decreased amount of food, and diagnosed as the Spleen Qi deficiency by the score of Spleen Qi Deficiency Questionnaire (SQDQ) over 48.86 - Subjects who give written informed consents

Exclusion criteria

Exclusion criteria: - Diabetes mellitus(Having past history or fast blood sugar over 126?/? at screening test), History of liver disease(hepatitis, hepatocirrhosis) or abnormality of liver function(AST or ALT over 60U/L at screening), abnormality of renal function(Creatinine over 1.2 ?/? at screening), heart disease(heart failure, angina, heart failure, arrhythmia), history of cancer - Possibility of anorexia nervosa, bulimia nervosa, or other similar disorders (applicants satisfying the DSM-IV criteria for eating disorder and those who scored =88 in the Bulimia Test Revised or =21 in the Korean Version of Eating Attitude Test-26 were eliminated) - Drinking alcohol more than three times a week in recent three months - Change of body weight more than 5% of the present weight in recent three months - Having irregular meal pattern(Not eating breakfast, eating breakfast before 6am or after 10am more than three times a week) - Attending different clinical trial - During pregnancy or breast-feeding, or having plan of pregnacy, or disagreement of proper contraception in fertile women

Design outcomes

Primary

Measure	Time frame
Changes of the total scores of Spleen Qi Deficiency Questionnaire (SQDQ) from the baseline to the week 4	—

Secondary

Measure	Time frame
Changes of the respective scores of sub-items of Spleen Qi Deficiency Questionnaire (SQDQ) from the baseline to the week 4;Changes of the body weight from the baseline to the week 4;Changes of the scores of the subjective appetite ratings from the baseline to the week 4;Changes of the 1 day-energy intake from the baseline to the week 4;Changes of the Gastrointestinal Symptom Rating Scale(GSRS) scores from the baseline to the week 4;Change of the Functional Dyspepsia Related Quality of Life(FD-QoL) score between the baseline(week 0) and the week 4;Changes of the Korean-Beck Depression Inventory(KBDI) scores from the baseline to the week 4;Changes of the Fatigue Severity Scale (FSS) scorse from the baseline to the week 4;Changes of the Simplified Nutritional Appetite Questionnaire (SNAQ) scores from the baseline to the week 4;Changes of the Bristol stool scale scores from the baseline to the week 4;Changes of the pre-prandial(0min) plasma gut hormone (total peptide YY (PYY), active ghrelin, pancreatic polypeptide(PP), active GLP-1) levels from the baseline to the week 4;Change of post-prandial(30min) plasma gut hormone(total peptide YY (PYY), active ghrelin, pancreatic polypeptide(PP), active GLP-1) levels from the baseline to the week 4;Changes of the gap betewen pre and post-prandial(0-30min) plasma gut hormone(total PYY, active ghrelin, pancreatic polypeptide(PP), active GLP-1) levels from the baseline to the week 4;Changes of blood test levels (FBS, Triglyceride, Total cholesterol, HDL-cholesterol, Hemoglobin, TIBC, Protein, Albumin) from the baseline to the week 4	—

Measure

Time frame

Changes of the respective scores of sub-items of Spleen Qi Deficiency Questionnaire (SQDQ) from the baseline to the week 4;Changes of the body weight from the baseline to the week 4;Changes of the scores of the subjective appetite ratings from the baseline to the week 4;Changes of the 1 day-energy intake from the baseline to the week 4;Changes of the Gastrointestinal Symptom Rating Scale(GSRS) scores from the baseline to the week 4;Change of the Functional Dyspepsia Related Quality of Life(FD-QoL) score between the baseline(week 0) and the week 4;Changes of the Korean-Beck Depression Inventory(KBDI) scores from the baseline to the week 4;Changes of the Fatigue Severity Scale (FSS) scorse from the baseline to the week 4;Changes of the Simplified Nutritional Appetite Questionnaire (SNAQ) scores from the baseline to the week 4;Changes of the Bristol stool scale scores from the baseline to the week 4;Changes of the pre-prandial(0min) plasma gut hormone (total peptide YY (PYY), active ghrelin, pancreatic polypeptide(PP), active GLP-1) levels from the baseline to the week 4;Change of post-prandial(30min) plasma gut hormone(total peptide YY (PYY), active ghrelin, pancreatic polypeptide(PP), active GLP-1) levels from the baseline to the week 4;Changes of the gap betewen pre and post-prandial(0-30min) plasma gut hormone(total PYY, active ghrelin, pancreatic polypeptide(PP), active GLP-1) levels from the baseline to the week 4;Changes of blood test levels (FBS, Triglyceride, Total cholesterol, HDL-cholesterol, Hemoglobin, TIBC, Protein, Albumin) from the baseline to the week 4

—

Countries

Korea, Republic of

Contacts

Public ContactHye-won Oh

Kyung Hee University Oriental Medical Center

ohw0321@naver.com

Outcome results