Symptoms and General Pathology

All Conditions

Neoplasms

Mouth and Tooth Diseases

Digestive System Diseases

Ulcer

Head and Neck Neoplasms

Stomatitis

Mucositis

Gastroenteritis

Gastrointestinal Diseases

Mouth Diseases

Stomatognathic Diseases

The treatment group receive Herbal gargle 150ml and are instructed to hold the gargle in the mouth for 30s and then expectorate it twice a day, 5 days a week for 8 weeks.

The control group receive Normal saline 150ml and are instructed to hold the normal saline in the mouth for 30s and then expectorate it twice a day, 5 days a week for 8 weeks.

Herbal gargle

Normal saline

Yi-Hsine Shiao, Doctor

The aim of the study is to evaluate the effects of Herbal gargle on chemoradiotherapy-induced stomatitis in head \& neck cancer patients.

Head and neck cancer accounts for about 5% of all cancers worldwide with the age-standardized incidence rate (ASIR) of HNC increased by 5.4% per year among males and 3.1% among females in Taiwan. Concurrent chemoradiotherapy (CCRT) is the most common management to treat head and neck cancer. However, CCRT may cause much side effects such as oral mucositis, radiation dermatitis, xerostomia, or infection, which influence food intake, disturb nutritional status and interrupt the course of treatment. Traditional Chinese Medicine (TCM) has been applied to treat cancer side effects for many years. Herbal gargle is composed of TCM herbals used for oral mucositis induced by chemoradiotherapy among head and neck cancer. The aim of the trial is to evaluate the effectiveness of Herbal gargle. The participants divide into two groups, treatment group and control group. The treatment group receive Herbal gargle 150ml and are instructed to hold the gargle in the mouth for 30s and then expectorate it twice a day, 5 days a week for 8 weeks. The control group receive normal saline 150ml for oral mucositis. The subjective questionnaires of EORTC QLQ-C30, EORTC QLQ-H\&N35 are assessed twice a week, CTCAE for grading of oral mucositis is assessed once a week, VAS is assessed everyday for 8 weeks. Besides, change of opioid dosage, body weight are also recorded. The CRP is assessed before and every week for 8 weeks and the albumin and bacteria culture are assessed before and post-treatment of 4th week and 8th week. The baseline difference of treatment and control group will be analyzed by using independent t-test and the difference of evaluation scores and blood tests between pre-treatment and post-treatment will be analyzed using multivariate logistic regression analysis. A value of P \< 0.05 will be regarded as statistically significant for the above statistical analyses.

The treatment group receive Herbal gargle and control group receive normal saline.

The color of Herbal gargle is yellowish while normal saline is transparent. Therefore, the study belongs to open label trial.

Evaluation the Effects of Herbal Gargle for Chemoradiotherapy-induced Oral Mucositis of Head & Neck Cancer, a Pilot Study.

CTCAE is used to describe the severity of oral mucositis for patients receiving cancer therapy.

European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire score, EORTC QLQ-C30, is used to measure cancer patients' physical, psychological and social functions.

European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-head \& neck, EORTC QLQ-H\&N35, is used for assessing the health-related quality of life for head-and-neck cancer patients.

Visual Analogue Scale, VAS, is used to to measure the intensity of pain of oral mucositis.

The oral mucositis caused by chemoradiotherapy will influence food intake. Monitor body weight provides objective evaluation of nutrition status.

Opioid analgesics is often prescribed for alleviating pain from oral mucositis. Monitor opioid use provides other evaluation for severity of pain and wound healing.

Albumin has been used as maker of nutrition status.

C-reactive protein is used to monitor severity of oral mucositis.

Aerobic culture is used to monitor the change of bacteria flora before and after Herbal gargle treatment.

Chang Gung Memorial Hospital

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Nervous System Diseases

Rare Diseases

Ovarian Neoplasms

Pain

Pelvic Pain

Endometriosis

Uterine Neoplasms

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Neurologic Manifestations

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Uterine Diseases

Ovarian Cancer

Chinese Acupuncture

Peter Wayne, PhD

The purpose of this study is to evaluate the safety and effectiveness of acupuncture in treating women's health conditions.

This trial comprises three studies. In the first two studies, women will be randomly assigned to receive either real or sham acupuncture therapy. Study 1 will include women with various forms of cancer. White blood cell counts will be used to assess the effects of acupuncture on participants' immune responses. Study 2 will include women with unspecified pelvic pain and endometriosis; a self-report pain scale will be used to assess the effects of acupuncture on participants' symptoms. Study 3 will evaluate the validity and reliability of diagnoses made by Chinese medicine practitioners. In this study, a group of Chinese medicine practitioners will diagnose the same group of patients; consistency of the diagnoses will be evaluated.

Acupuncture for Women's Health Conditions

New England School of Acupuncture (NESA) Acupuncture Research Collaborative

National Center for Complementary and Integrative Health (NCCIH)

Mouth Neoplasms

Oral Cancer

Patients who meet the inclusion criteria and agree to receive concomitant treatment with SZKJT.

The SZKJT samples were made and packed by Kaiser Pharmaceutical Co. Ltd. with lot number of 2019023247.

SZKJT(San-Zhong-Kui-Jian-Tang)

Ming-Yu Lien, Ph.D

The goal of this clinical trial is to learn about the clinical efficacy of San-Zhong-Kui-Jian-Tang (SZKJT), a formula of Chinese medicine in head and neck cancer patients receiving concurrent chemoradiotherapy (CCRT) treatments. The main questions it aims to answer are:

* Can SZKJT improve the completion rate of CCRT?
* Can SZKJT reduce the adverse effects of CCRT?
* How SZKJT affect the quality of life in the patients receiving CCRT
* How about the safety of using SZKJT in the patients receiving CCRT

Participants will be asked to:

* take SZKJT for 9 weeks during the whole CCRT course
* take questionnaires of quality of life

San-Zhong-Kui-Jian-Tang (SZKJT) is originated from the Secret Treasure of the Orchid Chamber written by Gao Li (AC1180 - 1251). SZKJT contains 16 herbs to treat abnormal swelling or nodules. In the theory of Chinese medicine, SZKJT can clear heat and resolve toxin, which leads to disperse swelling and binds in nodules.

The purpose of this study is to explore the clinical efficacy and safety of SZKJT in improving the completion rate of concurrent chemoradiotherapy (CCRT) in patients with head and neck cancer, and to evaluate the prevention and treatment effects of SZKJT on the side effects of chemoradiotherapy, as well as the improvement of quality of life.

The primary endpoint of the study is the completion rate of CCRT under SZKJT treatment. The secondary endpoints are adverse effects of CTCAE, body constitution questionnaire (BCQ) and the EORTC core quality of life questionnaire (QLQ-C30). Liver and kidney functions are considered as well for adverse effects of SZKJT. We hypothesized that additional SZKJT with CCRT might improve completion rate of CCRT and reduce severity of adverse effects of CCRT.

A Pilot Study of Additional Chinese Formula for Concurrent Chemoradiotherapy in Oral Cavity Cancer Patients

We counted the percentage rate of those who achieved and did not reach the CCRT course.

We apply Common Terminology Criteria for Adverse Events (CTCAE) to assess the adverse effects of CCRT.

We assess the patients' quality of life by using the European Organisation for Research and Treatment of Cancer (EORTC) quality-of-life questionnaire QLQ-C30.

We assess the patients' constitutions of traditional Chinese medicine by using Body Constitution Questionnaire (BCQ).

We monitor the liver function of the patients by blood chemistry analysis. The levels of Alanine transaminase (ALT) and Aspartate transaminase (AST) are recorded as units per liter.

We monitor the renal function of the patients by blood chemistry analysis. The levels of blood urine nitrogen (mg/dL) and creatinine (mg/dL) are recorded. Glomerular filtration rate (GFR) is estimated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Creatinine Equation (2021).

China Medical University Hospital

Respiratory Tract (Lung and Bronchial) Diseases

Syndrome

Lung Neoplasms

Using questionnaire to collect data from new lung cancer patients.

Constitution in Chinese Medicine Questionnaire

Su-Tso Yang, M.D.

Recently, TCM has played an important role in adjuvant therapy for lung cancer. TCM treatment is based on pattern identification, and constitution theory is also used as a tool for TCM to predict the disease progression. Although there have been many researchs related to the pattern identification and constitution of lung cancer, in view of the problems and limitations, further research on lung cancer patients in Taiwan is needed.

This study aims to explore the correlation between TCM constitution, pattern identification, and other related factors in patients with primary lung cancer in Taiwan, hoping to reveal the disease characteristics of lung cancer in TCM theory. This study intends to interview subjects through attending physicians in the thoracic ward and outpatient clinic of the CMUH from November 20th, 2023 to May 19th , 2025, and the subjects will be included in this study after the researchers ask the subjects for consent.

This study will collect the demographic data of the subjects (sex, age, BMI, smoking history) and disease-related clinical data (tumor stage, pathological type, gene mutation, tumor markers, other comorbidities), and the investigator will ask about the subjects' signs according to the Constitution in Chinese Medicine Questionnaire (CCMQ) , ask the subjects' symptoms according to the pattern identification table, obtain the data to analyze their distribution by descriptive statistics, and then analyze the correlation between them by analysis of variance and Chi-square test.

TCM Constitution, Pattern Types, and Disease Factors in Primary Lung Cancer.

A Study on the Correlation Between TCM Constitution, Pattern Types, and Disease Factors in Primary Lung Cancer.

Ask about the subjects' signs according to the Constitution in Chinese Medicine Questionnaire (CCMQ)

Ask about the subjects' symptoms according to the pattern identification table

tumor stage, pathological type, gene mutation, tumor markers, other comorbidities

Skin and Connective Tissue Diseases

Leiomyoma

Myofibroma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Neoplasms, Connective Tissue

Connective Tissue Diseases

Anti-Infective Agents

All Drugs and Chemicals

Gastrointestinal Agents

Vitamins

Herbal and Botanical

Acetic Acid

Turmeric extract

Calcium Carbonate

Turmeric

Astragalus

Subjects in this arm receive high dose (217 g/day) TSD for 16 weeks.

Subjects in this arm receive low dose (69 g/day) TSD for 16 weeks.

TSD is composed of 15 individual Chinese medicines: Astragalus Membranaceus, Semen Coicis, Poria, Curcuma longa L, and Fritillaria Thunbergii Miq, Cassia twig, Pollen typhae, Resina draconis, Lithospermum erythrorhizon, Halloysitum Rubrum, Rhizoma Corydalis processed with vinegar, Hirudo, Calcined corrugated sub , Oyster Shell and Laminaria Japonica Aresch.

High dose (127g) or Low dose (69g) TSD decoction boiled as 200ml per bag; 2 bags per day, 6 days per week; Orally in-take one bag of TSD decoction in morning and another in evening after meal; The whole treatment lasts for 16 weeks.

Wei Meng

On the basis of empirical evidence and clinical practice, the investigators have developed a formula called Tumor-shrinking Decoction (TSD) used in the treatment of uterine fibroids (UFs). The investigators preliminary clinical observation has demonstrated the benefits of TSD in improving UFs.

TSD is composed of 15 individual Chinese medicines: Astragalus Membranaceus, Semen Coicis, Poria, Curcuma longa L, and Fritillaria Thunbergii Miq, Cassia twig, Pollen typhae, Resina draconis, Lithospermum erythrorhizon, Halloysitum Rubrum, Rhizoma Corydalis processed with vinegar, Hirudo, Calcined corrugated sub , Oyster Shell and Laminaria Japonica Aresch.

It is hypothesized that TSD can effectively reduce the fibroid size and improve the symptoms associated with UFs and the greater anti-tumor potency of TSD is associated with higher therapeutic doses.

To test this hypothesis, one 16-week, double-blind, randomized, two-dose trial will be conducted in patients with symptomatic UFs to determine whether the high dose (217 g/day) of TSD could produce significantly greater effects in reducing the fibroid size and improving its related symptoms and biochemical profiles compared to the lower dose (69 g/day).

Numerous Chinese medicine preparations have been shown to possess therapeutic potential in relieving uterine fibroids (UFs) symptoms and shrinking the volume of fibroids without significant adverse effects, although the clinical efficacy needs to be further confirmed with rigorously designed.On the basis of empirical evidence and clinical practice, the investigators have developed a formula called Tumor-shrinking Decoction (TSD) used in the treatment of UFs. The investigators preliminary clinical observation has demonstrated the benefits of TSD in improving UFs.

TSD is composed of 15 individual Chinese medicines. According to traditional Chinese medicine (TCM) doctrine, most UFs are developed due to the deficiency of vital energy and the stasis of blood, resulting in the formation of pathological massive tissues. Individual Chinese medicines constituting TSD can be classified into three classes based on TCM-defined pharmacological actions: (i) Tonifying qi and resolve phlegm: Astragalus Membranaceus, Semen Coicis, Poria, Curcuma longa L, and Fritillaria Thunbergii Miq; (ii) Resolve stasis, stopping bleeding and relieve pain: Cassia twig, Pollen typhae, Resina draconis, Lithospermum erythrorhizon, Halloysitum Rubrum, Rhizoma Corydalis processed with vinegar; and (iii) Softening hardness and dissipate binds: Hirudo, Calcined corrugated sub , Oyster Shell and Laminaria Japonica Aresch.

Indeed, the investigators previous studies of cultured cells and animals have revealed that TSD robustly inhibits fibroid cell growth and proliferation. The investigators therefore hypothesize that TSD can effectively reduce the fibroid size and improve the symptoms associated with UFs and the greater anti-tumor potency of TSD is associated with higher therapeutic doses.

To test this hypothesis, one 16-week, double-blind, randomized, two-dose trial will be conducted in patients with symptomatic UFs to determine whether the high dose (217 g/day) of TSD could produce significantly greater effects in reducing the fibroid size and improving its related symptoms and biochemical profiles compared to the lower dose (69 g/day).

Study of Tumor-shrinking Decoction (TSD) to Treat Symptomatic Uterine Fibroids

A Double-blind, Randomized, Two-dose Trial of Tumor-shrinking Decoction (TSD), a Chinese Medicine Preparation in Patients With Symptomatic Uterine Fibroids

Adverse events will be closely monitored at each visit. All adverse events, reported, elicited or observed, will be recorded on case report form, including the date and time of onset, duration, severity, relationship to study drug, and action taken.

UFS-QOL consists of 37 items to assess the severity of UFs-related symptoms and the quality of life of patients.

The secondary clinical outcome is the clinical response that is defined as a ≥30% baseline-to-endpoint reduction on the symptom severity of transformed UFS-QOL score.

Imaging outcomes will be examined at baseline and endpoint using magnetic resonance imaging (MRI) scan to determine the number, size and density of the uterine fibroids.

two blood samples will be collected from each patient at baseline and at the end of the study, respectively. The collection of blood will be conducted between 08:00 and 09:00 before meal. Sera will be separated and stored at -20ºC until assayed. Serum concentrations of estrogen, progesterone and follicle-stimulating hormone will be measured using chemiluminescent immunoassay (CLIA).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluation the Effects of Herbal Gargle for Chemoradiotherapy-induced Oral Mucositis of Head & Neck Cancer, a Pilot Study.	NCT05341206	Head and Neck N... Chemoradiothera... Stomatitis and ...	Herbal gargle Normal saline	20 Years -	Chang Gung Memorial Hospital
Acupuncture for Women's Health Conditions	NCT00090389	Ovarian Neoplas... Endometriosis Pelvic Pain Uterine Neoplas...	Chinese Acupunc...	18 Years -	National Center for Complementary and Integrative Health (NCCIH)
A Pilot Study of Additional Chinese Formula for Concurrent Chemoradiotherapy in Oral Cavity Cancer Patients	NCT05590650	Head and Neck N... Chemoradiothera...	SZKJT(San-Zhong...	20 Years - 65 Years	China Medical University Hospital
Acupuncture for Women's Health Conditions	NCT00090389	Ovarian Neoplas... Endometriosis Pelvic Pain Uterine Neoplas...	Chinese Acupunc...	18 Years -	National Center for Complementary and Integrative Health (NCCIH)
TCM Constitution, Pattern Types, and Disease Factors in Primary Lung Cancer.	NCT06143436	Medicine, Chine... Body Constituti... Syndrome Risk Factors	Constitution in...	18 Years - 100 Years	China Medical University Hospital
Evaluation the Effects of Herbal Gargle for Chemoradiotherapy-induced Oral Mucositis of Head & Neck Cancer, a Pilot Study.	NCT05341206	Head and Neck N... Chemoradiothera... Stomatitis and ...	Herbal gargle Normal saline	20 Years -	Chang Gung Memorial Hospital
TCM Constitution, Pattern Types, and Disease Factors in Primary Lung Cancer.	NCT06143436	Medicine, Chine... Body Constituti... Syndrome Risk Factors	Constitution in...	18 Years - 100 Years	China Medical University Hospital
Study of Tumor-shrinking Decoction (TSD) to Treat Symptomatic Uterine Fibroids	NCT02189083	Leiomyoma	TSD	18 Years - 52 Years	The University of Hong Kong
Study of Tumor-shrinking Decoction (TSD) to Treat Symptomatic Uterine Fibroids	NCT02189083	Leiomyoma	TSD	18 Years - 52 Years	The University of Hong Kong
A Pilot Study of Additional Chinese Formula for Concurrent Chemoradiotherapy in Oral Cavity Cancer Patients	NCT05590650	Head and Neck N... Chemoradiothera...	SZKJT(San-Zhong...	20 Years - 65 Years	China Medical University Hospital

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