Health Condition 1: K760- Fatty (change of) liver, not elsewhere classified
Conditions
Interventions
Intervention1: TurmXtra 60N (Water dispersible Turmeric extract) capsule 250 mg: Dose:250 mg,
Frequency:Once Daily,
Route of Administration:Oral,
Duration of Therapy:84 ± 2 Days
Control Intervent
Sponsors
Inventia Healthcare Limited India
Laila Nutraceuticals
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the efficacy of TurmXtra 60N (Water dispersible Turmeric extract) capsule 250 mg in subjects with NAFLDTimepoint: The primary Outcome will be assessed data obtained on 84 ± 2 day. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the safety and tolerability of TurmXtra 60N (Water dispersible Turmeric extract) capsule 250 mg in subjects with NAFLDTimepoint: The secondary Outcome will be assessed data obtained on 84 ± 2 day. | — |
Countries
India
Contacts
Public ContactDr Sandeep Singh
CBCC Global Research LLP
Outcome results
None listed