Nigeria Clinical Trial Registry Federal Ministry of Health Federal Secretariat Complex Shehu Shagari Way, Garki, Abuja Telephone: +27 21 938 0506 / +27 21 938 0834     Fax: +27 21 938 0836 Email: info@nhrec.ne Trial No: 0 Date registered: 2024-03-05 Trial Status: Pending TRIAL DESCRIPTION Public title SINGLE-CENTRE/MULTI-GROUP/OPEN/RANDOMIZED/PLACEBO-CONTROLLED 30 WEEKS PHASE I CLINICAL TRIAL OF ANCILLA DOMINI PREVENTIVE/CURATIVE FOODS ON DIABETES (II); HYPERTENSION/ CARDIAC ARRHYTHMIAS; OBESITY AN Official scientific title SINGLE-CENTRE/MULTI-GROUP/OPEN/RANDOMIZED/PLACEBO-CONTROLLED 30 WEEKS PHASE I CLINICAL TRIAL OF ANCILLA DOMINI PREVENTIVE/CURATIVE FOODS ON DIABETES (II); HYPERTENSION/ CARDIAC ARRHYTHMIAS; OBESITY AND GASTROINTESTINAL TRACT (GIT) ULCERS. Brief summary describing the background and objectives of the trial We discovered NANO BIOTECH INVERSE TRANSCRIPTOR 1.9.90 (N-BIT1.9.90) for discovering drugs Following a 2-decade research, we have discovered/produced permanent cure/preventions for: HYPERTENSION DIABETES (II) GIT ULCERS OBESITY NORMALIIZATION in food forms. Our ambition is to stimulate a paradigm shift from drug-based healthcare system marred by side effects to a food-based healthcare system devoid of side effects, hence, develop an abacus for AFRICAN PHARMACOPEIA/DEVELOPMENT (APaD). Type of trial Treatment Acronym (If the trial has an acronym then please provide) SINGLE-CENTRE/MULTI-GROUP/OPEN/RANDOMIZED/PLACEBO-CONTROLLED 30 WEEKS PHASE I CLINICAL TRIAL OF ANCILLA DOMINI PREVENTIVE/CURATIVE FOODS ON DIABETES (II); HYPERTENSION/ CARDIAC ARRHYTHMIAS; OBESITY AN Disease(s) or condition(s) being studied HYPERTENSION/CARDIAC ARRHYTHMIAS; DIABETES (II); OBESITY DECIMATION/NORMALIZATION; GASTRO-INTESTINAL TRACT ULCERS Purpose of the trial Anticipated trial start date 2024-04-15 Actual trial start date 2024-04-22 Anticipated date of last follow up 2024-11-18 Actual date of last follow up 2024-11-25 Anticipated target sample size (number of participants) 100    Actual target sample size (number of participants) 35    Recruitment status Not yet recruiting No Secondary ID Issuing authority/Trial register 1 1 1 STUDY DESIGN Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used Single group Non-randomised 1 sealed opaque envelopes. 1 Participants,Outcome Assessors,1 INTERVENTIONS Intervention type Intervention name Dose Duration Intervention description Group size Nature of control Experimental group dgrviwoa 1 1 1 Active Control group nbmxyaxi 1 1 1 Active Experimental group opicgrhh 1 1 1 Placebo Control group oeqonksh 1 1 1 Placebo Experimental group bkvtlsmy 1 1 1 Historical Control group lrjwbdsa 1 1 1 Uncontrolled Experimental group djkfgswy 1 1 1 Uncontrolled Control group fwedfgae 1 1 1 Historical Experimental group ncbfnmyn 1 1 1 Dose comparison Control group uoqkquom 1 1 1 Dose comparison ELIGIBILITY CRITERIA List inclusion criteria List exclusion criteria Min age Max age Gender 1 1 1 1 1 ETHICS APPROVAL Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee 0000-00-00 0000-00-00 mciacekw Ethics Committee Address Street address City Postal code Country 3137 Laguna Street San Francisco 94102 Afghanistan 0000-00-00 0000-00-00 oohbxeng Ethics Committee Address Street address City Postal code Country 3137 Laguna Street San Francisco 94102 Afghanistan OUTCOMES Type of outcome Outcome Timepoint(s) at which outcome measured Secondary Outcome 1 1 RECRUITMENT CENTRES Name of recruitment centre Street address City Postal code Country 1 3137 Laguna Street San Francisco 94102 Afghanistan 1 3137 Laguna Street San Francisco 94102 Albania 1 3137 Laguna Street San Francisco 94102 Algeria FUNDING SOURCES Name of source Street address City Postal code Country SPONSORS Sponsor level Name Street address City Postal code Country Nature of sponsor COLLABORATORS Name Street address City Postal code Country FAIZA TIJJANI TASHI SCHOOL OF NURSING, KANO Kano 700241 Nigeria CONTACT PEOPLE Role Name Email Phone Fax