An interventional study of ACV Moringa Effervescent Tablets 4.3 g and Placebo Effervescent Tablets 4.3 g in Obese or Overweight Healthy Volunteers, sponsored by NovoBliss Research Pvt Ltd. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-08-01.
Sponsored by NovoBliss Research Pvt Ltd · Not applicable, Interventional, and Treatment
A Randomized, Double-Blind, Placebo-Controlled, Two-Arm, Single-Centre, Clinical Study to Evaluate the Safety and Efficacy of Intake of ACV Moringa on the Degree of Weight Change in Overweight and Class I Obese Study Participants
This is randomized, double-blinded, single-centre placebo-controlled, two-arms, clinical safety and efficacy study on Overweight and Obese (Class-I) subjects to evaluate the degree of weight change by regular intake of ACV Moringa.
A total of 66 participants (33 Subjects per Test Treatment), including males and non-pregnant, non-lactating females aged between 18 and 65 years, who are overweight/ obese class-I subjects will be enrolled in the study. Participants will be randomized in a 1:1 ratio to receive either Treatment A or Treatment B. The study aims to complete evaluation for 46 participants (23 Subjects per Test Treatment) for the study.
The potential subjects will be screened on the basis of the inclusion and exclusion criteria only after obtaining the written informed consent from the subjects. Subjects will be pre-screened by the Screening Department at NovoBliss Research based on their Body Mass Index (BMI). Subjects will be called contacted telephonically by the recruiting department prior to the enrolment visit. The subject will be requested to bring any previous medications and relevant laboratory reports on the day of the study visit. The subject will be asked to bring the past medications or laboratory reports along with on the study visit day.
The subjects will be instructed to visit the facility as per the below visits:
Telephonic Follow-up: A structured telephonic follow-up schedule as mentioned below will be implemented to ensure adherence to study instruction, including diet restrictions and exercise routines. Additionally, daily text messages reminders will be sent to all enrolled subjects.
Parameters include Anthropometric Parameters, Body composition, Athletic Endurance, Glycemic Parameters, Lipid Metabolism, Metabolic Markers, Inflammatory Biomarkers, Craving Control Biomarkers, Subjective Evaluation, Hematological Profile, Serum Biochemistry
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's planned enrollment of 66 is close to the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →NovoBliss Research Pvt Ltd is the lead sponsor of 47 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Mode of Usage: Dissolve one effervescent tablet in a full glass of water in 200 mL. Allow it to fully dissolve before consuming. For best results, consume the solution immediately after preparation before the fizz ends. Frequency: Twice daily, once before lunch and once before dinner Storage condition: Room temperature (15°C to 30°C) Route of Administration: Oral
Other: Placebo Effervescent Tablets 4.3 g
Mode of Usage: Dissolve one effervescent tablet in a full glass of water in 200 mL. Allow it to fully dissolve before consuming. For best results, consume the solution immediately after preparation before the fizz ends. Frequency: Twice daily, once before lunch and once before dinner Storage condition: Room temperature (15°C to 30°C) Route of Administration: Oral
Other: ACV Moringa Effervescent Tablets 4.3 g
Mode of Usage: Dissolve one effervescent tablet in a full glass of water in 200 mL. Allow it to fully dissolve before consuming. For best results, consume the solution immediately after preparation before the fizz ends. Frequency: Twice daily, once before lunch and once before dinner Storage condition: Room temperature (15°C to 30°C) Route of Administration: Oral
Mode of Usage: Dissolve one effervescent tablet in a full glass of water in 200 mL. Allow it to fully dissolve before consuming. For best results, consume the solution immediately after preparation before the fizz ends. Frequency: Twice daily, once before lunch and once before dinner Storage condition: Room temperature (15°C to 30°C) Route of Administration: Oral
Change in body weight using calibrated weighing machine
To assess the efficacy of test treatment by evaluating change in body weight in Kg assessed within each treatment group and across treatment groups
Time frame: Day 01 (pre-treatment), Day 45 (+2 days), and Day 90 (+2 days)
Change in Anthropometric Parameters using calibrated measuring tape
To assess the efficacy of test treatment by evaluating change in Anthropometric Parameters (Body weight in kg Waist circumference in cm Hip circumference in cm Height in meter and BMI) assessed within each treatment group and across treatment groups.
Time frame: Day 01 (pre-treatment), Day 45 (+2 days), and Day 90 (+2 days)
Change in total Fat percentage using Bioimpedance Test
To assess the efficacy of test treatment by evaluating change in total Fat percentage assessed within each treatment group and across treatment groups
Time frame: Day 01 (pre-treatment), Day 45 (+2 days), and Day 90 (+2 days)
Change in VO2 Max using Treadmill Walking Test
To assess the efficacy of test treatment by evaluating change in VO2 Max (mL/kg/min) assessed within each treatment group and across treatment groups.
Time frame: Day 01 (pre-treatment), Day 45 (+2 days), and Day 90 (+2 days)
Change in Apolipoprotein - ApoA, ApoB
To assess the efficacy of test treatment by evaluating change in Apolipoprotein (mg/dL) - ApoA, ApoB assessed within each treatment group and across treatment groups.
Time frame: Day 01 (pre-treatment), Day 45 (+2 days), and Day 90 (+2 days)
Change in carbohydrate metabolism through Serum Blood Glucose and PPBG
To assess the efficacy of test treatment by evaluating change in carbohydrate metabolism (mg/dL or mmol/L) assessed within each treatment group and across treatment groups.
Time frame: Day 01 (pre-treatment), Day 45 (+2 days), and Day 90 (+2 days)
Change in Lipid metabolism through Total Cholesterol, HDL, LDL, Triglycerides
To assess the efficacy of test treatment by evaluating change in Lipid metabolism (mg/dL or mmol/L) assessed within each treatment group and across treatment groups.
Time frame: visit 01 (30 Days from Day 01) Day 01 (pre-treatment), Day 45 (+2 days), and Day 90 (+2 days)
Change in Fatty Acid Oxidation Rate through Beta-hydroxybutyrate
To assess the efficacy of test treatment by evaluating change in Fatty Acid Oxidation Rate (mmol/L) assessed within each treatment group and across treatment groups.
Time frame: Day 01 (pre-treatment), Day 45 (+2 days), and Day 90 (+2 days)
Change in Metabolic Biomarkers through HOMA-IR
To assess the efficacy of test treatment by evaluating change in Metabolic Biomarkers assessed within each treatment group and across treatment groups.
Time frame: Day 01 (pre-treatment), and Day 90 (+2 days)
Change in Inflammatory Biomarkers through IL-6, CRP
To assess the efficacy of test treatment by evaluating change in Inflammatory Biomarkers (IL-6 -pg/mL and CRP- mg/L) assessed within each treatment group and across treatment groups
Time frame: Day 01 (pre-treatment), Day 45 (+2 days), and Day 90 (+2 days)
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jul 2025; primary completion for Oct 2025, 3 months later.
Of 3,680 non-industry interventional studies with no phase under Obesity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's planned 3 months is below that.
Counting every sponsor, half of 3,843 studies reached it within 22 months; a quarter within 10 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
NovoBliss Research Pvt Ltd