Evaluation of the Efficacy and Safety of Hyaluronic Acid Vaginal Gel to Ease Vaginal Dryness: A Multicenter, Randomized, Controlled, Open‐Label, Parallel‐Group, Clinical Trial

2013 ◽  
Vol 10 (6) ◽  
pp. 1575-1584 ◽  
Author(s):  
Junya Chen ◽  
Li Geng ◽  
Xuehong Song ◽  
Hongxia Li ◽  
Nicola Giordan ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Hyaluronic Acid ◽  
Efficacy And Safety ◽  
Open Label ◽  
Vaginal Dryness ◽  
Randomized Controlled ◽  
Vaginal Gel ◽  
Parallel Group

scholarly journals Evaluation on immediate analgesic efficacy and safety of Kai-Hou-Jian spray (children’s type) in treating sore throat caused by acute pharyngitis and tonsillitis in children: study protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Yan-ning Ma ◽  
Cheng-liang Zhong ◽  
Si-yuan Hu ◽  
Qiu-han Cai ◽  
Sheng-xuan Guo
Keyword(s):  
Clinical Trial ◽  
Sore Throat ◽  
Controlled Trial ◽  
Analgesic Efficacy ◽  
Effective Rate ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Acute Pharyngitis ◽  
Randomized Controlled ◽  
Parallel Group

Abstract Background Acute pharyngitis and tonsillitis are common respiratory diseases for which children seek medical care. Their main clinical manifestation is sore throat which interferes with patients’ quality of life. However, there is no proven effective or safe method to treat it. It is necessary to find an excellent strategy to reduce sore throat and reduce the burden of acute illness. We designed the randomized controlled trial with the characteristics of traditional Chinese medicine (TCM) to determine the clinical positioning of Kai-Hou-Jian spray (children’s type) (KHJS) through evidence-based research. This trial aims to evaluate the immediate analgesic efficacy of KHJS on sore throat caused by acute pharyngitis and tonsillitis (wind-heat syndrome/heat exuberance in lung and stomach syndrome) in children and to observe its safety. Methods/design This is a prospective, multicenter, randomized, double-blind, parallel-group, placebo-controlled trial. It will include 240 children with acute pharyngitis/tonsillitis from 7 study sites across China. All participants are randomly assigned to two parallel treatment groups, one with KHJS and the other with placebo sprays, for 5 consecutive days. The primary outcome is the time of analgesic onset. Secondary outcomes include duration of analgesic effect, area under time curve of 0–3 h Wong-Baker FACES Pain Rating Scale (WBS) score (AUC0-3 h), rate of analgesic onset, rate of disappearance of sore throat, changes of WBS score (in days), effective rate of pharyngeal signs, and effective rate of TCM syndrome. The incidence of adverse events during the trial is the primary safety outcome. In addition, vital signs and laboratory tests before and after medication are monitored. Discussion To our knowledge, this will be the first clinical trial to explore the immediate analgesic efficacy of a Chinese patent medicine spray for acute pharyngitis/tonsillitis induced sore throat in children in a multicenter, randomized, double-blinded, parallel-group, placebo-controlled manner. Not only might it prove the efficacy and safety of KHJS in the treatment of sore throat caused by acute pharyngitis/tonsillitis in children, but it might also provide evidence for the treatment of acute sore throat with Chinese herbal medicine. Trial registration A multicenter, randomized, double-blind, very low-dose, parallel controlled trial for the immediate analgesic effect and safety of Kai-Hou- Jian spray (children's type) in the treatment of sore throat caused by acute pharyngitis and tonsillitis in children. Chinese Clinical Trial Registry ChiCTR2000031599. Registered on 5 April 2020

scholarly journals Baidu Jieduan granule, traditional Chinese medicine, in the treatment of moderate coronavirus disease-2019 (COVID-19): study protocol for an open-label randomized controlled clinical trial

2020 ◽  
Author(s):  
Wen Zhang ◽  
Qin Xie ◽  
Xiaoming Xu ◽  
Shuting Sun ◽  
Tian Fan ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Controlled Trial ◽  
Theory And Practice ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety ◽  
Open Label ◽  
Randomized Controlled

Abstract Background: Currently, coronavirus disease-2019 (COVID-19) is continuously and rapidly circulating, resulting in serious and extensive impact on human health. Due to the absence of antiviral medicine for COVID-19 thus far, it is desperately need to develop the effective medicine. Traditional Chinese medicine (TCM) has been widely applied in the treatment of epidemic diseases in China, hoping to produce clinical efficacy and decrease the use of antibiotics and glucocorticoid. The aim of this study is to evaluate the efficacy and safety of Baidu Jieduan granule in curing COVID-19. Methods/design: This multicenter, open-label randomized controlled trial is conducted 300 cases with COVID-19. The patients will be randomly (1:1) divided into treatment group or control group. All cases will receive standard therapy at the same time. The experiment group will receive Baidu Jieduan granule treatment twice a day for 14 days. The outcomes are assessed at baseline and at 3, 5, 7, 14 days after treatment initiation. The primary outcome is the rate of symptom (fever, fatigue, and coughing) recovery. Adverse events (AEs) will be monitored throughout the trial.Discussion: The study will provide a high-quality clinical evidence to support the efficacy and safety of Baidu Jieduan granule in treatment of moderate COVID-19, and also enrich the theory and practice of TCM in treating COVID-19. Trial registration: Chinese Clinical Trial Registry, ChiCTR2000029869. Registered on 15 February 2020

Efficacy and Safety of Traditional Chinese Medicine in COVID-2019: A Study Protocol for an Open-Label, Multicenter Randomized Controlled Trial

2020 ◽  
Author(s):  
Congcong Zeng ◽  
Zhengzhong Yuan ◽  
Xiaoqiong Pan ◽  
Jizhou Zhang ◽  
Jiahui Zhu ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Outcome Measures ◽  
Lung Injury Score ◽  
Secondary Outcome ◽  
Control Group ◽  
Efficacy And Safety ◽  
Open Label ◽  
Randomized Controlled

Abstract Introduction: The outbreak of a novel coronavirus (SARS-CoV-2) and associated COVID-19 disease in late December 2019 has led to a global pandemic. It directly leads to high morbidity and mortality, but also results in a devastating effect on the global economy. Unfortunately, there are no effective therapies or vaccines for it. Hence, we designed a randomized trial to evaluate the efficacy and safety of Traditional Chinese Medicine for treating patients with COVID-19.Methods and analysis: This is an open-label, multicenter randomized controlled clinical trial. One hundred and twelve patients infected by SARS-CoV-2 will be randomly assigned to the experimental or the control group in an equal ratio. The patients in control group will accept routine supportive clinically care including the therapies of anti-viral, anti-bacterial and ameliorating the related symptoms, while patients in the experimental group will be asked to take traditional Chinese medicine depending on the different stages of the disease for consecutive 14 days in addition to supportive care. All data will be gathered at baseline and on days 3, 7, 10 and 14. The primary outcome measures will be the time of Reverse Transcription PCR testing of respiratory tract sample turns to be negative. Secondary outcome measures will include Murray lung injury score, MuLBSTA score and TCM ( Traditional Chinese Medicine ) Syndrome Scoring System. A laboratory test will be taken before and after treatment to assess the safety of TCM.Discussion: The study may help to identify the the efficacy and safety of Traditional Chinese Medicine in treating COVID-2019.Trial registration: Chinese Clinical Trial Registry, ChiCTR2000030759.Registered on March 13th 2020-Retrospectively registered, http://www.chictr.org.cn/.

Mycophenolate Mofetil (CellCept®) for Psoriasis: A Two-Center, Prospective, Open-Label Clinical Trial

2003 ◽  
Vol 7 (3) ◽  
pp. 193-197 ◽  
Author(s):  
Youwen Zhou ◽  
Don Rosenthal ◽  
Jan Dutz ◽  
Vincent Ho
Keyword(s):  
Clinical Trial ◽  
Mycophenolate Mofetil ◽  
Controlled Trial ◽  
Treatment Phase ◽  
Severity Index ◽  
Severe Psoriasis ◽  
Efficacy And Safety ◽  
Periorbital Edema ◽  
Open Label ◽  
Randomized Controlled

Background: Mycophenolate mofetil (MMF) is an immune suppressant that selectively inhibits activated lymphocytes. Its usefulness in treating psoriasis has not been systematically investigated. Objective: To evaluate efficacy and safety of MMF as a monotherapy for psoriasis. Methods: This is a two-center, prospective, open-label clinical trial. Results: Twenty-three patients with moderate to severe psoriasis [mean psoriasis area and severity index (PASI) of 21.7] were treated with MMF 2–3 g/day for 12 weeks. Eighteen patients completed the study. The PASI was reduced by 24% ( p < 0.001) at 6 weeks, and by 47% ( p < 0.001) at 12 weeks. At the end of the treatment phase, 77% of the patients had significant reduction of PASI while 22% did not respond. The treatment was well tolerated. Five patients experienced mild nausea. One patient each had periorbital edema and pruritus. One patient had transient leukopenia. Conclusion: In this noncontrolled trial, the majority of patients with moderate to severe psoriasis responded to mycophenolate mofetil monotherapy with few adverse events. A randomized, controlled trial should be considered to confirm the usefulness of MMF as a monotherapy for psoriasis.

scholarly journals Efficacy and safety of two Ayurvedic dosage forms for allergic rhinitis: Study protocol for an open-label randomized controlled trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Jeevani Maheshika Dahanayake ◽  
Pathirage Kamal Perera ◽  
Priyadarshani Galappaththy ◽  
Dulani Samaranayake
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Allergic Rhinitis ◽  
Dosage Forms ◽  
Efficacy And Safety ◽  
Open Label ◽  
Randomized Controlled ◽  
Nasal Symptoms ◽  
Freeze Dried

Abstract Background Allergic rhinitis (AR) is an immune response of the nasal mucosa to airborne allergens and involves nasal congestion, watery nasal discharge, itching of the nose, and sneezing. The symptoms of allergic rhinitis may significantly affect a patient’s quality of life and can be associated with conditions such as fatigue, headache, cognitive impairment, and sleep disturbances. Various complementary and alternative medicine treatments have been used for this condition in clinical practice. The Ayurveda system of medicine is the most common complementary medicine system practiced in Sri Lanka. The aim of this study is to examine the efficacy and safety of a decoction used in traditional Ayurveda for allergic rhinitis and its ready- to-use freeze dried formulation in comparison to an antihistamine over a period of 4 weeks on relief of symptoms in allergic rhinitis. Study design This is a three-arm, open-label, non-inferiority, randomized controlled clinical trial enrolling patients with AR. Tamalakyadi decoction containing 12 ingredients (TMD12), used in traditional Ayurveda and its freeze-dried formulation are the test products. The efficacy and safety of the two Ayurvedic dosage forms will be tested against the antihistamine loratadine. Patients with symptoms of AR will be allocated randomly into the three arms after a 1-week run-in period and the medications will be given orally for 28 days. Total Nasal symptom Score (TNSS) of the patients will be used as the primary efficacy endpoint. TNSS will be recorded and compared between the three arms prior to visit 1, at the end of 28 days, and end of the first and second months of follow-up. Symptom scores of daytime nasal symptoms, night time nasal symptoms, non-nasal symptoms and health-related quality of life questionnaire are used as secondary end points. Discussion This clinical trial will be able to provide evidence-based scientific data on Ayurvedic dosage form, TMD12, and the freeze-dried formulation in the treatment of allergic rhinitis. This trial is expected to develop capacity to scientifically evaluate various Ayurvedic treatments that are claimed to have efficacy in treatment of various disease conditions. Trial registration ISRCTN18149439 (6 May 2019).

scholarly journals The Efficacy and Safety of Indocyanine green- hyaluronic acid mixture (LuminoMarkTM) for Localization in Patients with Non-palpable Breast Lesions: A Multi-center Open-label Parallel Phase-2 Clinical trial

2021 ◽  
Author(s):  
isaac kim ◽  
Hee Jun Choi ◽  
Jai Min Ryu ◽  
Se Kyung Lee ◽  
Jong Han Yu ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Hyaluronic Acid ◽  
Skin Pigmentation ◽  
Test Group ◽  
Acid Mixture ◽  
Control Group ◽  
Breast Lesions ◽  
Efficacy And Safety ◽  
Open Label ◽  
Palpable Breast

Abstract Backgrounds With increasing screening for breast cancer, non-palpable breast lesions are detected more frequently. A preoperative localization is very important for a minimal but accurate excision of a non-palpable breast lesion. The purpose of this study was to evaluate the efficacy and safety of indocyanine green(ICG)-hyaluronic acid mixture injection as a novel material for localization. Methods We performed prospective clinical trial with female patients who underwent surgery for non-palpable breast lesion. All patients were sequentially assigned to the control group(localization with activated charcoal), test group 1(ICG-hyaluronic acid mixture 0.1ml), or test group 2(ICG-hyaluronic acid mixture 0.2ml) by 1:1:1 ratio. Results A total of 44 patients were eligible for this study (control group = 14, test 1 group = 15, test 2 group = 15 patients ). Among all patients, Fibroadenoma accounted for the largest share (38.6%, 17/44) and malignancy accounted for 11.4% (5/44). There was no difference in baseline characteristics in three groups. The marking rate was over 86% in all groups, and there was no difference. However, skin pigmentation was only in the control group and the accuracy of resection (the greatest length in cm of the excised specimen divided by the greatest length in cm on the pre-operation ultrasound image, the value closer to 1 meant resection as much as the size on ultrasound image) was different significantly. The average was 3.7 in control group and 2.2 in test 1 group and 2.1 in test 2 group. ( p-value was 0.037 between control and test 1 group, 0.744 between test 1 and test 2 group, 0.026 between control and test2 group respectively. ) Conclusion ICG-hyaluronic acid mixture injection is a new method for localization with non-palpable breast lesions, as well as a better method with higher accuracy of resection, lower skin pigmentation. Further research is required to apply this method to malignant breast lesions.Trial registration “A Multi-center Open-label Parallel Phase-2 Clinical trial to evaluate the efficacy and safety of LuminoMarkTM for Localization in Patients with Non-palpable Breast Lesions” was prospectively registered as a trial (ClinicalTrials. gov Identifier: NCT03743259, date of registration: May 29, 2018, https://clinicaltrials.gov/ct2/show/NCT03743259).

scholarly journals Efficacy and Safety of Ayurveda Intervention AYUSH 64 as add-on therapy for patients with COVID 19 infections: An open labelled, Parallel Group, Randomized controlled clinical trial

2021 ◽  
Author(s):  
Pankaj Bhardwaj ◽  
Pawan Kumar Godatwar ◽  
Jaykaran Charan ◽  
Sanjeev Sharma ◽  
Shazia Shafi ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Sample Size ◽  
Standard Treatment ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety ◽  
Randomized Controlled Clinical Trial ◽  
Rt Pcr ◽  
Randomized Controlled ◽  
Parallel Group

COVID-19 pandemic impacted human health and the global economy. There is a huge uncertainty about the management of this disease, many drugs including some older drugs are being tested for efficacy and safety including the medicines from the complementary and alternative system. The Central Council for Research in Ayurvedic Sciences, India's apex body for Ayurvedic research and development under the Ministry of AYUSH, has developed a poly-herbal drug called AYUSH 64 for covid 19 which is considered to be having role in the COVID-19. This study was designed with the aim of assessing the efficacy and safety of AYUSH 64 in mild covid-19 patients as add on therapy with standard treatment. It was an open labelled, comparative, parallel group, Randomized controlled clinical trial. Total 60 stage I (mild) COVID 19 positive subjects were recruited, 30 were assigned to AYUSH 64 as an add on therapy along with the standard treatment and 30 were assigned to standard treatment as per the protocols. RT-PCR test was done as per government guidelines and protocol. Along with the RT-PCR clinical laboratory tests were also performed at screening as well as on the discharge as per the study schedule. Absolute events of negative RT-PCR at day 5 were more in the AYUSH 64 group as compared to control group but it was not statistically significant (70% Vs 54%, p=0.28). There was no significant difference between AYUSH 64 and control group for fever and respiratory symptoms or important lab parameters. No serious adverse event was reported from any group. AYUSH 64 has no significant beneficial effect as compared to control group, this may be because of the less sample size or no actual effect which need to be confirmed by studies with large sample size.

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