Tokyo, Jan. 30 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060506) titled 'Human studies on the immune function of Sendan alpha' on Jan. 29.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Double blind -all involved are blinded Control - Placebo

Primary Sponsor: Institute - Southen Knight' Laboratory Co., Ltd.

Condition: Condition - Healthy people Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - Sendan alpha is a product containing extracts derived from the plant Melia azedarach, and has been shown to have potent anti-cancer activity in human tumor cells and in mouse and dog tumor models. Sendan alpha is also sold as a supplement claiming to have immune-modulating and anti-tumor effects, but scientific proof from large-scale human clinical trials is still insufficient. Therefore, we decided to conduct a human trial of Sendan alpha and examine the immunostimulatory effects of this product on immune function through blood tests. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - The test product used was commercially available Sendan alpha (a 50ml bottle containing 2.5mg of Melia azedarach leaf extract, as well as small amounts of erythrityl, monk fruit extract/seasoning (amino acids, etc.), acidulant, flavouring (derived from apple), sweetener (stevia, acesulfame K), L-arginine, preservative (sodium benzoate), calcium pantothenate, nicotinamide, and vitamins B1, B6 and B2). Interventions/Control_2 - The diluted product used is commercially available Sendan alpha (a 50ml bottle contains 1.5mg of Melia azedarach leaf extract, and also contains small amounts of erythrityl, monk fruit extract/seasoning (amino acids, etc.), acidulant, flavouring (derived from apple), sweetener (stevia, acesulfame potassium), L-arginine, preservative (sodium benzoate), calcium pantothenate, nicotinamide, and vitamins B1, B6 and B2).

Eligibility: Age-lower limit - 50 years-old = Gender - Male and Female Key inclusion criteria - Healthy men and women aged 50-79 Key exclusion criteria - Participants who meet any of the following criteria will be excluded: 1. Participants currently undergoing treatment for neoplastic, infectious, or immune-related diseases. 2. Participants who consume specified health foods, health foods, supplements, or nutritional drinks daily or frequently. 3. Participants with food or drug allergies. 4. Participants with difficulty communicating. 5. Participants whose physicians have otherwise determined that enrollment in this study is inappropriate. Target Size - 60

Recruitment Status: Recruitment status - Completed Date of protocol fixation - 2025 Year 08 Month 01 Day Date of IRB - 2025 Year 08 Month 05 Day Anticipated trial start date - 2025 Year 11 Month 04 Day Last follow-up date - 2025 Year 12 Month 26 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067137

Disclaimer: Curated by HT Syndication.