CTRI/2020/03/023814Other未知
A randomized, double-blind, multi-center, two-arm, parallel, placebo-controlled study to evaluate the safety and efficacy of TurmXtra 60N (Water dispersible Turmeric extract) capsule 250 mg on Hepatic function markers in subjects with Non Alcoholic Fatty Liver Disease (NAFLD) - NA
Inventia Healthcare Limited India0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- Other
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •The subjects must meet all of the inclusion criteria:
- •1. Subjects must be able to provide voluntary written informed consent and to follow protocol requirements
- •2. Male and female subjects aged between 18 to 65 years both inclusive
- •3. Subjects diagnosed with NAFLD grades 1 to 3 based on liver ultrasonography
- •4. Subjects with fatty liver index greater than or equal to 60 calculated by below formula
- •FLI is equal to (ey)/ (1 + ey) Ã? 100
- •Where y is equal to 0.953 Ã? loge(triglycerides) + 0.139 Ã? BMI + 0.718 Ã? loge(GGT) + 0.053 Ã? waist circumference - 15.745
- •5. Elevated liver function markers AST and ALT greater than ULN
- •6. Willingness to complete subject diaries
- •7. Women of childbearing potential defined as women physiologically capable of becoming pregnant unless they are using effective method of contraception during dosing of the IP practicing acceptable methods of contraception
- •Acceptable methods of contraception are
- •a. Oral or other for example injection patch or implant hormonal contraception which has been used continuously for at least one month prior to the first dose of study medication
- •b. Intrauterine device IUD or intrauterine system IUD or IUS
- •c. Double barrier method of contraception condom and occlusive cap or condom and spermicidal agent
- •d. Male sterilization at least 6 months prior to the screening should be the sole male partner for that subject
- •e. Female sterilization surgical bilateral oophorectomy or tubal ligation at least 6 weeks prior to study participation
- •f. Total abstinence partial abstinence is not acceptable
- •8. No history of addiction to any recreational drug or drug dependence
排除标准
- •The subjects must not meet any of the following exclusion criteria:
- •1.Hypersensitivity to any of the components of IP or any of the ingredients of the formulations.
- •2.Fatty liver secondary to alcohol consumption
- •3.Subjects on drugs / supplements associated with impairment of liver function
- •4.Subjects using hypolipidemic medications as well as any drug known to affect hepatic function 4 weeks prior to randomization
- •5.Subjects with history or presence of any other liver and gall bladder disease
- •6.Difficulty in swallowing and retaining oral formulation
- •7.Pregnant or lactating women
- •8.History or presence of any uncontrolled debilitating systemic disease (including but not limited to cardiovascular disease, hypertension, diabetes mellitus type I and II, chronic kidney disease etc.).
- •9.Subjects having undergone major surgical procedure (including periodontal) within 28 days prior to the first dose of IP.
- •10.Subjects with positive serology for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or Human Immunodeficiency Virus (HIV)
- •11.Participation in any clinical study within 30 days prior to receiving the first dose of IP.
- •12.Any other medical condition or serious intercurrent illness that, in the opinion of the investigator, may make it undesirable for the subject to participate in the study including but not limited to psychiatric illness/social situations that would limit adherence to study requirements.
研究者
相似试验
进行中（未招募）
不适用
A multicenter, randomized, double-blind, two-arm, vehicle-controlled, parallel-group, two stage study to evaluate and demonstrate the efficacy and to evaluate the safety of pimecrolimus 1% cream in the treatment of seborrhoeic dermatitis in patients 12 years of age and olderSeborrhoeic Dermatitis (SD)MedDRA version: 8.1Level: LLTClassification code 10039793Term: Seborrhoeic dermatitisEUCTR2006-003984-30-DEovartis Pharma Services AG690
进行中（未招募）
1 期
Sodium Alginate Chewable Tablet European Symptom Relief Study for patients with symptoms of GORDGastro-Oesophageal Reflux Disease (GORD)MedDRA version: 20.1Level: LLTClassification code 10018203Term: GERDSystem Organ Class: 100000004856EUCTR2014-005261-69-ITRECKITT BENCKISER HEALTHCARE (UK) LIMITED424
进行中（未招募）
不适用
A Multi-center, Randomized, Double-blind, Two-Arm, Phase III Study in Patients with Untreated Stage III Unresectable or IV Melanoma Receiving Dacarbazine Plus 10mg/kg of Ipilimumab MDX-010 vs. Dacarbazine With Placebo - CA184-024ntreated stage III unresectable or IV melanoma.MedDRA version: 6.1Level: HLTClassification code 10027156EUCTR2005-006082-14-ITBristol Myers Squibb S.r.L.500
进行中（未招募）
1 期
Sodium Alginate Chewable Tablet European Symptom Relief Study for patients with symptoms of GORDEUCTR2014-005261-69-DEReckitt Benckiser Healthcare (UK) Limited493
进行中（未招募）
1 期
Sodium Alginate Chewable Tablet European Symptom Relief Study for patients with symptoms of GORDEUCTR2014-005261-69-GBReckitt Benckiser Healthcare (UK) Limited424