Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Syndrome

Polycystic Ovary Syndrome

Cysts

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Gonadal Disorders

Endocrine System Diseases

Participants in this group will receive an oral 550 mg Berberine supplement tablet BDS for 3-months as an add-on to the changes in the diet/life-style for 3-months. The changes in the diet/life-style include limiting fat and carbohydrate intake and improve dietary behavior without the application of a calorie-restricted diet program. Exercise will also be recommended to include 30 min/day of moderate to intense activity.

Participants in this group will undergo changes in their diet/life-style.

550 mg Berberine supplement BDS for 3-months + changes in diet/life style.

Berberine

Berberine is a plant alkaloid, reportedly possesses a wide range of pharmacological activities, including anti-obesity and anti-dyslipidemia. Berberine is an effective insulin sensitizer and has a comparable activity to MET in reducing IR. A large body of evidence suggest that Berberine dietary supplementation helps in improvement of symptoms associated with Polycystic Ovary Syndrome (PCOS). The purpose of this study is to investigate the treatment benefits of Berberine in women with PCOS.

Berberine (BBR) is an isoquinoline derivative alkaloid that occurs in several plants including Oregon grape, barberry, tree turmeric, goldenseal, yellowroot, Amur corktree, Chinese goldthread, prickly poppy and Californian poppy.

Berberine supplementation has been suggested to improve the symptoms associated with PCOS. Berberine;

Reduces Insulin Resistance Lowers Blood Sugar Levels Aids in Weight Loss Improves Cholesterol Levels Regulates Menstrual Cycles Reduces Inflammation Helps Restore Hormonal Balance Improves Fertility Helps Combat Depression Helps Fight Fatty Liver Disease Improves Body Composition

The present RCT is aimed to investigate the effect of Berberine on these symptoms associated with PCOS.

Treatment Benefits of Berberine Supplementation for Women With PCOS

Effect of Berberine Supplementation on Metabolic and Hormonal Features in Women With Polycystic Ovary Syndrome (PCOS)

High density lipoprotein cholesterol (HDL-C)

Low density lipoprotein cholesterol (LDL-C)

Ayub Teaching Hospital

Infertility

Antineoplastic Agents

All Drugs and Chemicals

Letrozole

Aromatase Inhibitors

Enzyme Inhibitors

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormones

Hormone Antagonists

Letrozole

2.5 mg letrozole daily from day 5 of the menses for 5 days for month 1 to 3, 5.0 mg letrozole daily from day 5 of the menses for 5 days for month 4 to 6.

Berberine

1.5g daily for 6 month.

Letrozole -Berberine

Letrozole

2.5 mg letrozole daily from day 5 of the menses for 5 days for month 1 to 3, 5.0 mg letrozole daily from day 5 of the menses for 5 days for month 4 to 6.

Berberine Placebo

5 tablet tds for 6 months

Berberine

1.5g daily for 6 month.

Letrozole placebo

1 tablet daily from day 5 of the menses for 5 days for month 1 to 3, 2 tablets daily from day 5 of the menses for 5 days for month 4 to 6.

Yan Li, MD.PhD.

Hongxia Ma, MD

Xiaoke Wu, MD.PhD.

Lihui Hou, MD.

Polycystic ovary syndrome (PCOS) is a heterogeneous disorder affecting almost4%-7% of the female population of reproductive age. Its heterogeneity is characterized by a wide spectrum of features, including ovulatory dysfunction and infertility, hyperandrogenism, hyperinsulinemia, insulin resistance (IR), and progression to type 2 diabetes.Since the Ming Dynasty in China,PCOS has been defined as "phlegm and wetness"infertility in traditional Chinese medicine ,namely "metabolic infertility".Chinese herbs have been used to treat PCOS for thousands of years with good effects.Berberine has also been used for diabetic patients in traditional Chinese medicine for hundreds of years. Recent studies have reported its effects on hyperglycemia and dyslipidemia.The purpose of this study is to determine whether Letrozole combined with berberine are effective in the treatment of infertile PCOS patients.

Polycystic Ovary Syndrome (PCOS): Effect Of Letrozole and Berberine

Letrozole and Berberine in Infertile PCOS Patients

Ministry of Science and Technology of the People´s Republic of China

Heilongjiang University of Chinese Medicine

Professor and Department Chairman of Obstetrics and Gynecology

Digestive System Diseases

Infections

Rare Diseases

Stomach Neoplasms

Communicable Diseases

Ulcer

Gastritis

Stomach Ulcer

Gastrointestinal Diseases

Stomach Diseases

Gastroenteritis

Peptic Ulcer

Duodenal Diseases

Intestinal Diseases

Stomach Cancer

Chronic Graft Versus Host Disease

Anti-Infective Agents

Gastrointestinal Agents

Amoxicillin

Esomeprazole

Bismuth

Tetracycline

Furazolidone

Anti-Bacterial Agents

Antacids

Anti-Ulcer Agents

Proton Pump Inhibitors

Anti-Infective Agents, Local

Antiprotozoal Agents

Antiparasitic Agents

Monoamine Oxidase Inhibitors

Berberine 500mg three time daily for 14days, amoxicillin 1000 mg, esomeprazole 20 mg, and Bismuth 200mg by mouth, twice daily for 14 days.

Tetracycline 500mg three time daily for 14days，furazolidone 100 mg, esomeprazole 20 mg, and Bismuth 200mg by mouth, twice daily for 14 days.

Berberine-amoxicillin quadruple therapy group: given for 14 days at a dose of berberine 100 mg 3 tablets TID, amoxicillin 500 mg 2 capsules BID ，esomeprazole 20 mg BID, ,and Bismuth 100 mg 2 capsules BID.

Berberine-amoxicillin quadruple therapy group: given for 14 days at a dose of Amoxicillin 500 mg 2 capsules BID plus berberine 100 mg 3 tablets TID, esomeprazole 20mg 1tablet BID, and bismuth 100 mg 2 capsules BID

Berberine-amoxicillin quadruple therapy group: given for 14 days at a dose of Esomeprazole 20mg 1 tablet BID plus berberine 100 mg 3 tablets TID,amoxicillin 500 mg 2 capsules BID, and bismuth 100 mg 2 capsules BID

Tetracycline-furazolidone containing quadruple therapy group: given for 14 days at a dose of Tetracycline 250mg 2 capsules TID plus furazolidone 100mg 1 tablets BID，esomeprazole 20 mg 1 tablets BID and bismuth 100 mg 2 capsules BID

Tetracycline-furazolidone containing quadruple therapy group: given for 14 days at a dose of Tetracycline 250mg 2 capsulesTID plus furazolidone 100mg 1 tablets BID，esomeprazole 20 mg 1 tablets BID and bismuth 100 mg 2 capsules BID

Tetracycline-furazolidone containing quadruple therapy group: given for 14 days at a dose of furazolidone 100mg 1 tablets BID plus Tetracycline 250mg 2 capsulesTID，esomeprazole 20 mg 1 tablets BID and bismuth 100 mg 2 capsules BID

Tetracycline-furazolidone containing quadruple therapy group: given for 14 days at a dose of esomeprazole 20 mg 1 tablets BID plus Tetracycline 250mg 2 capsules TID, furazolidone 100mg 1 tablets BID， and bismuth 100 mg 2 capsules BID

Tetracycline-furazolidone containing quadruple therapy group: given for 14 days at a dose of bismuth 100 mg 2 capsules BID plus Tetracycline 250mg 2 capsules TID ，furazolidone 100mg 1 tablets BID and esomeprazole 20 mg 1 tablets BID

This study aims at evaluating efficacy and safety of berberine- amoxicillin containing quadruple therapy(berberine, amoxicillin, esomeprazole and bismuth) versus tetracycline-furazolidone quadruple therapy (tetracycline, furazolidone, esomeprazole and bismuth) in H. pylori rescue therapy. It is hypothesized that berberine-amoxicillin containing quadruple therapy is non-inferior to tetracycline-furazolidone quadruple therapy. Patients with confirmed failure of H. pylori eradication will be randomized to one of the treatments described above. At week 6 follow-up visits, a urea breath test，rapid urease test or helicobacter pylori stool antigen test will be performed to confirm eradication.

Detailed Description:

The study will include three phases: screening, treatment and follow-up. Screening: this phase will last a maximum of 14 days and subjects eligibility will be evaluated after signing informed consent. One of urea breath test，rapid urease test or helicobacter pylori stool antigen test will be performed in addition to the baseline routine evaluations.

Treatment: Subjects are randomly assigned to treatment and will be treated for 14 days. A randomization visit will take place on Day 0 and an end-of-treatment visit will take place between day 13 and 17.

Follow-up: includes one visits. Approximately 28 days after the end of treatment. Eradication of H. Pylori will be confirmed by one of urea breath test，rapid urease test or helicobacter pylori stool antigen test。

Helicobacter Rescue Therapy With Berberine Plus Amoxicillin Quadruple Therapy Versus Tetracycline Plus Furazolidone Quadruple Therapy

Rescue Therapy for Helicobacter Pylori Eradication: A Randomized and Non-inferiority Trail of Berberine Plus Amoxicillin Quadruple Therapy Versus Tetracycline Plus Furazolidone Quadruple Therapy

The primary end point of this study is H.pylori eradication,established by negative urea breath test，rapid urease test or helicobacter pylori stool antigen test 28 days after the end of treatment.

Evaluation effective rate of symptoms 2 weeks of treatment and 4 weeks after the end of treatment.

Symptom effective rate =（total score before treatment - total score after treatment）/total score before treatment x 100%.

Total score = frequency \* severity.

Frequency score is calculated by all the frequency of heartburn, reflux, abdominal pain, and flatulence.

Severity is accumulated by the degree of symptoms described above, which is divided to 4 degree as 0 presenting none, and 3 presenting most severe

Participants with Adverse Events as a Measure of Safety and Tolerability.The common side effects of the study include headache, dizziness, skin rash, other gastrointestinal disorders, pyrexia, cough and back pain.

Xijing Hospital of Digestive Diseases

Professor

Nutritional and Metabolic Diseases

Obesity

Placebo

Zhuoran Wang, MD

Shiyu Han, MD

Berberine has showed effective in lowering blood sugar levels in db/db mice and anti-dyslipidemia in human.Studies on the effect of berberine on metabolic and hormonal features of women with polycystic ovary syndrome (PCOS) are lacking.The objective of this study is to examine the effect of Berberine metabolic and hormonal parameters and insulin resistance in obese patients with PCOS.

Effect of Berberine on Hormonal and Metabolic Features in Obese Women With Polycystic Ovary Syndrome (PCOS)

Effect of Berberine on Hormonal and Metabolic Features in Obese Women With PCOS

Glucose Disposal Rate measured by hyperinsulinemic euglycemic clamp

Professor and Chairman Dept Obs & Gyn, First Affiliated Hospital

Hypoglycemic Agents

Insulin

Insulin, Globin Zinc

2 daily oral doses (one before lunch and one dinner) of 550 mg of berberine tablets

Polycystic Ovary Syndrome (PCOS) is the most frequent endocrine disease in female reproductive-age. Recently, increasing evidence has shown that natural plant-based products may play a role in PCOS management. Previous study in PCOS preclinical model and in humans demonstrated that berberine is an effective insulin sensitizer and improves homeostasis of metabolic, inflammatory and hormonal disorders. However, to date there is no clinical study that considers globally all the activities carried out by berberine in PCOS clinical features. Given this background, aim of this study was to evaluate in normal-overweight PCOS women with normal menses the berberine effectiveness on: insulin resistance by Homeostasis Model Assessment (HOMA); inflammation by C-Reactive Protein (CRP), TNF-alpha; lipid metabolism; sex hormone profile and symptoms correlated to hyperandrogenism, such as acne, by Global Acne Grading System (GAGS) and Cardiff Acne Disability Index (CADI); body composition by dual-energy X-ray absorptiometry. All these parameters were collected at baseline and 60 days after supplementation with a new bioavailable and safe berberine formulation. Finally, adverse effects were assessed by liver and kidney functions. To evaluate statistically significant pre- post-supplementation changes, fitted a linear mixed model for each investigated endpoint was performed.

Berberine and Polycystic Ovary Syndrome

Berberine is an Effective Insulin Sensitizer and Improves Homeostasis of Metabolic and Hormonal Disorders in Women With Polycystic Ovary Syndrome: a Novel Treatment Strategy for PCOS

Homeostasis Model Assessment (pt), for evaluate insulin resistance if \> 2.4

Total Cholesterol (mg/dl), High Density Lipoprotein Cholesterol (mg/dl), Low Density Lipoprotein Cholesterol (mg/dl), Very Low Density Lipoprotein (mg/dl),Triglycerides (mg/dl)

Aspartate aminotransferase (IU/l), alanine aminotransferase (IU/l)

Gamma Glutamyl Transferase (U/I), Creatine Phosphokinase (U/I)

waist circumference (cm), hip circumference (cm)

Fat mass (g), lean mass (g), visceral adipose tissue (g)

Global Acne Grading System (scale): each type of acne lesion is given a value depending on severity: no lesions = 0, comedones = 1, papules = 2, pustules = 3, and nodules = 4. Each of the location was graded separately on 0-4 scale, with the most severe lesion within that location determining the local score. The severity was then graded according to the global score which is the summation of all local scores. A score of 1-6 was considered mild; 7-18, moderate; 19- 26, severe; and 27-32, very severe. The maximum score was 32

Cardiff Acne Disability Index (scale): the Cardiff Acne Disability Index consists of five questions with a Likert scale, four response categories (0-3). The five questions relate to feeling of aggression, frustration, interference with social life, avoidance of public changing facilities and appearance of the skin-all over the last month-and an indication of how bad the acne was now. The CADI score was calculated by summing the score of each question resulting in a possible maximum of 15 and minimum of 0. CADI scores were graded as low (0-4), medium (5-9), and high (10-15)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Treatment Benefits of Berberine Supplementation for Women With PCOS	NCT05480670	Polycystic Ovar...	Berberine	18 Years - 45 Years	Ayub Teaching Hospital
Polycystic Ovary Syndrome (PCOS): Effect Of Letrozole and Berberine	NCT01116167	Polycystic Ovar...	Letrozole -Berb... Letrozole Berberine	20 Years - 40 Years	Heilongjiang University of Chinese Medicine
Treatment Benefits of Berberine Supplementation for Women With PCOS	NCT05480670	Polycystic Ovar...	Berberine	18 Years - 45 Years	Ayub Teaching Hospital
Helicobacter Rescue Therapy With Berberine Plus Amoxicillin Quadruple Therapy Versus Tetracycline Plus Furazolidone Quadruple Therapy	NCT03609892	Gastric Ulcer Chronic Gastrit... Gastric Cancer Helicobacter Py... Gastritis	Berberine Amoxicillin Esomeprazole Bismuth Tetracycline Furazolidone Esomeprazole Bismuth	18 Years - 70 Years	Xijing Hospital of Digestive Diseases
Treatment Benefits of Berberine Supplementation for Women With PCOS	NCT05480670	Polycystic Ovar...	Berberine	18 Years - 45 Years	Ayub Teaching Hospital
Polycystic Ovary Syndrome (PCOS): Effect Of Letrozole and Berberine	NCT01116167	Polycystic Ovar...	Letrozole -Berb... Letrozole Berberine	20 Years - 40 Years	Heilongjiang University of Chinese Medicine
Effect of Berberine on Hormonal and Metabolic Features in Obese Women With Polycystic Ovary Syndrome (PCOS)	NCT01138930	Polycystic Ovar... Obesity	Berberine Placebo	18 Years - 35 Years	Heilongjiang University of Chinese Medicine
Berberine and Polycystic Ovary Syndrome	NCT04932070	Polycystic Ovar... Berberine	Berberine	20 Years - 35 Years	Azienda di Servizi alla Persona di Pavia
Berberine and Polycystic Ovary Syndrome	NCT04932070	Polycystic Ovar... Berberine	Berberine	20 Years - 35 Years	Azienda di Servizi alla Persona di Pavia
Effect of Berberine on Hormonal and Metabolic Features in Obese Women With Polycystic Ovary Syndrome (PCOS)	NCT01138930	Polycystic Ovar... Obesity	Berberine Placebo	18 Years - 35 Years	Heilongjiang University of Chinese Medicine
Helicobacter Rescue Therapy With Berberine Plus Amoxicillin Quadruple Therapy Versus Tetracycline Plus Furazolidone Quadruple Therapy	NCT03609892	Gastric Ulcer Chronic Gastrit... Gastric Cancer Helicobacter Py... Gastritis	Berberine Amoxicillin Esomeprazole Bismuth Tetracycline Furazolidone Esomeprazole Bismuth	18 Years - 70 Years	Xijing Hospital of Digestive Diseases

Spots Global Cancer Trial Database for berberine

Every month we try and update this database with for berberine cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for berberine

Every month we try and update this database with for berberine cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for berberine cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.