Osteo Arthritis Knee

JointAlive™

Placebo

FDA Drug Safety Communication: FDA strengthens warning that non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) can cause heart attacks or strokes

KGK Science Inc

Safety and Efficacy of JointAlive™ on the Knee-joint Function in Adults With Knee Arthritis

A Randomized, Double-blind, Placebo-controlled, Parallel Study to Investigate the Safety and Efficacy of JointAlive™ on Improving Knee Joint Function in Adults With Mild to Moderate Knee Osteoarthritis

This will be determined by change in pain of the identified knee joint from baseline to 12-week post-supplementation between JointAlive™ and placebo, as assessed by Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) pain and stiffness scores. Questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible score range of 0-20 for Pain. The lowest number represents no pain while the highest number represent extreme pain or stiffness. These are then converted to the Knee injury and Osteoarthritis Outcomes Score (KOOS) pain scores. KOOS scoring system ranges from 1-100, with 0 representing no pain and 100 being extreme pain.

This will be determined by change in stiffness of the identified knee joint from baseline to 12-week post-supplementation between JointAlive™ and placebo, as assessed by Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) pain and stiffness scores. Questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible 0-8 for Stiffness. The lowest number represents no pain or stiffness while the highest number represent extreme pain or stiffness. These are then converted to the Knee injury and Osteoarthritis Outcomes Score (KOOS) pain scores. KOOS scoring system ranges from 1-100, with 0 representing no stiffness and 100 being extreme stiffness.

Change in pain of the identified knee joint from baseline to 6-week post-supplementation between JointAlive™ and placebo, as assessed by Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) pain and stiffness scores. Questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible score range of 0-20 for Pain. The lowest number represents no pain while the highest number represent extreme pain or stiffness. These are then converted to the Knee injury and Osteoarthritis Outcomes Score (KOOS) pain scores. KOOS scoring system ranges from 1-100, with 0 representing no pain and 100 being extreme pain.

Change in stiffness of the identified knee joint from baseline to 6-week post-supplementation between JointAlive™ and placebo, as assessed by Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) pain and stiffness scores. Questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible 0-8 for Stiffness. The lowest number represents no pain or stiffness while the highest number represent extreme pain or stiffness. These are then converted to the Knee injury and Osteoarthritis Outcomes Score (KOOS) pain scores. KOOS scoring system ranges from 1-100, with 0 representing no stiffness and 100 being extreme stiffness.

KOOS Scores range from 0 to 100. A score of 0 indicates the worst possible knee symptoms and 100 indicates no knee symptoms.

The Scoring system ranges from 0 to 100, with 0 representing extreme problems and 100 representing no problems

The Scoring system ranges from 0 to 100, with 0 representing extreme problems with physical functions and 100 representing no problems

The Pain VAS questionnaire is a unidimensional measure of pain intensity. With the use of a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100 depending on pain intensity. A score of 0 represents no pain while a score of 100 represents extreme pain.

The Scoring system ranges from 0 to 100, with 0 representing poorest quality of life and 100 representing no problems

Diastolic and systolic blood pressure (BP) after 6 and 12 weeks of supplementation with JointAlive™

Heart rate (HR) after 6 and 12 weeks of supplementation with JointAlive™

Chenland Nutritionals Inc.

KGK Science Inc.

Basic treatment period (0 to 2rd week): Patients with infection of Helicobacter pylori receive rabeprazole (once 20 mg, twice a day), bismuth potassium citrate (once 0.3 g, twice a day), amoxicillin (once 1 mg, twice a day), and furazolidone (once 0.1 g, twice a day), and patients without infection of Helicobacter pylori only receive rabeprazole (once 20 mg, twice a day) and bismuth potassium citrate (once 0.3 g, twice a day).
Maintain treatment period (3rd to 6th week): Patients in this arm receive Hou Gu Mi Xi (once 10 g, twice a day).
Recuperation period (7th to 52th week): Patients in this arm receive Hou Gu Mi Xi (once 10 g, twice a day).
Extensional observational period (53 to 104 weeks): no intervention.

Basic treatment period (0 to 2rd week): Patients with infection of Helicobacter pylori receive rabeprazole (once 20 mg, twice a day), bismuth potassium citrate (once 0.3 g, twice a day), amoxicillin (once 1 mg, twice a day), and furazolidone (once 0.1 g, twice a day), and patients without infection of Helicobacter pylori only receive rabeprazole (once 20 mg, twice a day) and bismuth potassium citrate (once 0.3 g, twice a day).
Maintain treatment period (3rd to 6th week): Patients in this arm receive Hou Gu Mi Xi (once 10 g, twice a day) plus rabeprazole (once 10 mg, once a day).
Recuperation period (7th to 52th week): Patients in this arm receive Hou Gu Mi Xi (once 10 g, twice a day).
Extensional observational period (53 to 104 weeks): no intervention.

Basic treatment period (0 to 2rd week): Patients with infection of Helicobacter pylori receive rabeprazole (once 20 mg, twice a day), bismuth potassium citrate (once 0.3 g, twice a day), amoxicillin (once 1 mg, twice a day), and furazolidone (once 0.1 g, twice a day), and patients without infection of Helicobacter pylori only receive rabeprazole (once 20 mg, twice a day) and bismuth potassium citrate (once 0.3 g, twice a day).
Maintain treatment period (3rd to 6th week): Patients in this arm receive Placebo of Hou Gu Mi Xi (once 10 g, twice a day) plus rabeprazole (10 mg/d, qd).
Recuperation period (7th to 52th week): Patients in this arm receive Hou Gu Mi Xi (once 10 g, twice a day).
Extensional observational period (53 to 104 weeks): no intervention.

Basic treatment period (0 to 2rd week): Patients with infection of Helicobacter pylori receive rabeprazole (once 20 mg, twice a day), bismuth potassium citrate (once 0.3 g, twice a day), amoxicillin (once 1 mg, twice a day), and furazolidone (once 0.1 g, twice a day), and patients without infection of Helicobacter pylori only receive rabeprazole (once 20 mg, twice a day) and bismuth potassium citrate (once 0.3 g, twice a day).
Maintain treatment period (3rd to 6th week): Patients in this arm receive placebo of Hou Gu Mi Xi (once 10 g, twice a day).
Recuperation period (7th to 52th week): Patients in this arm receive Hou Gu Mi Xi (once 10 g, twice a day).
Extensional observational period (53 to 104 weeks): no intervention.

Peptic Ulcer Disease

Hou Gu Mi Xi is an oatmeal-liked, solid food (dry or dissolved eating).

Hou Gu Mi Xi

The placebo is as same as Hou Gu Mi Xi in respect of color, taste, and smell.

Rabeprazole is produced by Shanghai Xinyi Pharmaceutical Corp. Ltd.

Rabeprazole

Jiangxi University of Traditional Chinese Medicine

Efficacy and Safety of Hou Gu Mi Xi in Patients With Peptic Ulcer Diseases

Efficacy and Safety of Hou Gu Mi Xi in Patients With Peptic Ulcer Diseases: A Multicenter, Randomized, Double-blinded, Controlled Trial

The ulcer was classified for 6 grades:
A1: The ulcer is round or elliptical with the center covers thick and white fur; it can be accompanied by errhysis or blood clot, and was surrounded by the obvious flush, hyperemia and edema.
A2: The ulcer is covered by yellow or white fur, no bleeding, alleviated congestion and edema H1: The ulcer is healing, no hyperemia and edema disappear around the ulcer; the ulcer moss becomes thin, subside, accompanied by the new capillaries.
H2: The ulcer continuously changes to shallow and small. The surrounding mucosa plica centralized to the ulcer.
S1: The white fur of ulcer disappears and the new ulcer mucosa presents red. S2: The new ulcer mucosa goes from red to white.
Clinical cure: The ulcer heals with or without scar Markedly effective: The healing of ulcer reaches grade H2, or improves 2 grades Effective: The healing of ulcer reaches grade H1, or improves 1 grades Non-effective: No efficacy by the endoscopic observation

According to Pan et al's method, we will classify the quality of ulcer healing as three ranks by histological assessment: 1) good: integral villus and epithelium, many glands, good morphology, many blood capillary, and few inflammatory cells infiltration. 2) fair: short villus, incomplete or rough epithelium, less glands, structural distortion, few blood capillary, and moderate inflammatory cells infiltration; 3) poor: a little new epithelial cell, poor integrity of epithelium, poor morphology of villus and glands, very few blood capillary, and large amount of inflame cells.

This outcome will be assessed based on the Spleen Qi Deficiency Symptoms Grading and Quantifying Scale (SQD scale) score. Construct of SQD scale: A total of 15 items, of which 7 items assess main symptoms, including stomach pain, stomach distension, acid reflux, abdominal distension, powerless defecation, fatigue and weak, and inappetence; 8 items assess secondary symptoms, including stomach tightness, stomach burn, belching, nausea and vomiting, abnormal stool, tired mind and taciturnity, sallow complexion, and tastelessness and hypodipsia.
Scale ranges and explanations: Assessment of each item includes three aspects: degree, frequency in one day, and episodes within one week. The total score of each item is the sum of points of the three aspects. The higher score indicate the worse symptom. The items for assessing main symptoms are double weighted. The score range is 0 to 283 point.

For patients who have cured, ulcer is observed again under endoscope during the follow up period is considered as recurrence.

For patients infected with helicobacter pylori, the helicobacter pylori is considered as being eradicated when the result of 13C/14C-urea breath test goes from positive to negative

dioscorea nipponica/hemorrhage

Safety and Efficacy of JointAlive™ on the Knee-joint Function in Adults With Knee Arthritis

Efficacy and Safety of Hou Gu Mi Xi in Patients With Peptic Ulcer Diseases

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