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Healthy ParticipantsNCT07083947

Effect of Herbal Compositions on Body Weight, Body Composition and Metabolic Health in Overweight Subjects

A study testing CL19183 and CL24212 in people with Healthy Participants, run by ApexCPG LLC at 1 site in India.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The Purpose of the study is to evaluate the efficacy of herbal composition CL19183 and CL24212 on body weight, body composition and metabolic health in overweight subjects. Read more about this study

Who is it for?
Ages 22 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Participants
What is being tested?
CL19183 and CL24212
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
150 participants
Where
1 siteIndia
Study dates
16 Jul 2025to 25 Jan 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 22 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 1. Healthy male and female subjects aged between 25-55 years with body mass index (BMI) of 25-29.9 kg/m2.
  • 2. Subjects with sedentary lifestyle, no regular athletic or sports activities. 3. Subjects willing to participate in walking-exercise (5 days a week, 30 min per day) over study duration.
  • 4. Subjects with normal thyroid hormone profile. 5. Subjects agreed to consume recommended standard diet. 6. Subjects who are willing to abstain from alcohol, coffee, tea, cola, energy drinks \& chocolate for at least 24 hrs. prior to visits and final visit.
  • 7. Subjects who are non-smokers. 8. Subject agrees to maintain diet tracker. 9. Subject considered generally healthy as per health history and routine clinical investigations during screening.
  • 10. Female subjects of childbearing potential must be using a medically acceptable form of birth control for at least 1 month prior to screening (3 months on oral contraceptives), e.g., oral or patch contraceptives, intrauterine device, Depo-Provera®, or double-barrier and have a negative pregnancy test at the screening visit.
  • 11. Ability to understand the risks/benefits of the protocol and willing to sign the written informed consent.

Who cannot join

  • 1. Subjects who were taking medications which affect the metabolic rate (e.g. antidepressants, beta-blockers, hormones, etc.).
  • 2. Subjects on weight loss practices, usage of weight reduction supplements/nutrition products will be excluded.
  • 3. Subjects underwent treatment for COVID 19 within last 3 months or tested positive during the study will be excluded.
  • 4. Subjects participated in any weight loss programs within 3 months. 5. Subjects who are diabetic and/or hypertensive. 6. Evidence or history of hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic diseases, malignancies.
  • 7. Subjects taking medications for or suffering from a medical condition that could impact results related to metabolism (e.g., thyroid disorders, diabetes, mental disorders such as anxiety or depression, heart disease, arthritis, cancer).
  • 8. Subjects with HIV Positive. 9. Female subjects, who are pregnant, breast feeding or planning to become pregnant during the study.
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  • 10. Subjects having history of psychiatric disorder that may impair the ability of subjects to provide written informed consent.
  • 11. Any other condition that, in the opinion of the investigator, would adversely affect the subject's ability to complete the study or its measures.
  • 12. Use of nutritional supplements (e.g., creatine, protein drinks, amino acids, or vitamins) or ergogenic aids and caffeinated and not caffeinated thermogenics within 30 days prior to the study.
  • 13. Subjects who are participated or currently participating in another clinical trial within 30 days prior to screening.

Trial locations and contacts

1 site in 1 country.

India1 site

  • Swaroop Rani Hospital, Motilal Nehru Medical College

    Allahābād, Uttar Pradesh, 211002

Other trials in India

About this study

Official title: A Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate the Effect of Herbal Compositions CL19183 and CL24212 on Body Weight, Body Composition and Metabolic Health in Overweight Subjects

The Purpose of the study is to evaluate the efficacy of herbal composition CL19183 and CL24212 on body weight, body composition and metabolic health in overweight subjects.

Read the detailed description

A total of 150 male and female subjects aged between 25 and 55 years will be included in the study. Assessment of inclusion and exclusion criteria will be done based on clinical and laboratory investigations. The eligible subjects will be randomized as per the computer-generated randomization list. The subjects will be assigned to either CL19183:450 mg or CL24212:300 mg or Placebo arm at 1:1:1 ratio. The subjects will be instructed to take one capsule daily in the morning after breakfast for 16 weeks. Apart from primary and secondary outcomes, the study will also record the vital signs and adverse events to evaluate the herbal composition safety and tolerability. The safety assessment of the CL19183 and CL24212 will also include routine laboratory investigations on blood, urine and clinical chemistry at screening and the final visit of the intervention

Being tested
CL19183, CL24212, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CL19183Dietary supplement

    One capsule taken orally each morning after breakfast with water for 16 weeks

  • CL24212Dietary supplement

    One capsule taken orally each morning after breakfast with water for 16 weeks

  • PlaceboOther

    One capsule taken orally each morning after breakfast with water for 16 weeks

Study groups in NCT07083947
Study groupRoleWhat they receive
PlaceboPlacebo comparatorOne capsule taken orally each morning after breakfast with water for 16 weeks
Receives: Other: Placebo
CL19183ExperimentalOne capsule taken orally each morning after breakfast with water for 16 weeks
Receives: Dietary Supplement: CL19183
CL24212ExperimentalOne capsule taken orally each morning after breakfast with water for 16 weeks
Receives: Dietary Supplement: CL24212

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline to the end of the study period in Body weight

    The subject's body weight is measured using a digital weighing scale. An improvement is indicated when the body weight falls within the normal range based on the subject's demographic characteristics.

    Measured: Week 0 (Baseline), Week 2, Week 4, Week 8, Week 12 & Week 16

Secondary outcomes (14)

  1. Change from baseline to the end of the study period in Body mass index (BMI)

    Body mass index is a calculated measure by considering the weight and height of a subject. A change in BMI from overweight to normal range is a positive indicator of healthy lifestyle.

    Measured: Screening, Week 0 (Baseline),Week 2, Week 4, Week 8, Week 12 & Week 16

  2. Change from baseline to the end of the study period in Body composition using DEXA (including fat and lean mass)

    A low-dose X-ray is used to assess the fat and lean mass of a subject. An increase in lean mass indicates significant improvement, while a reduction in fat mass contributes to better overall health in the subject

    Measured: Week 0 (Baseline), Week 8& Week 16

  3. Change from baseline to the end of the study period in Waist (WC)

    Waist circumference is measured around the abdomen, just above the navel. This value is influenced by the subject's height and weight. A reduction in waist circumference indicates improvement in body weight, as well as decreased fat storage and deposition.

    Measured: Week 0 (Baseline),Week 2, Week 4,Week 8,Week 12,Week 16

  4. Change from baseline to the end of the study period in Hip circumference (HC)

    It represents the maximum circumference measured around the buttocks. This measurement is influenced by the subject's height and weight. A reduction in this value indicates improvements in body weight, as well as a decrease in fat storage and deposition

    Measured: Week 0 (Baseline),Week 2, Week 4,Week 8,Week 12,Week 16

  5. Change from baseline to the end of the study period in Waist to hip ratio (WHR)

    It's a ratio of waist to hip circumference. As the waist-to-hip ratio changes to the normal range according to person's demographic profile, this is associated with improvements in metabolism and body weight

    Measured: Week 0(Baseline), Week 2, Week 4, Week 8, Week 12& Week 16

  6. Change from baseline to the end of the study period in Lipid profile (including amyloid A)

    Amyloid A (AA) is derived from serum amyloid A (SAA), an acute-phase reactant produced predominantly by the liver during inflammation, including obesity, which can lead to elevated levels of serum amyloid A (SAA). In AA amyloidosis, amyloid deposits typically affect the kidneys (leading to proteinuria and renal impairment.

    Measured: Week 0 (Baseline), Week 8 & Week 16

  7. Change from baseline to the end of the study period in Lipid profile (including Apo B)

    Apo B is a protein found on the surface of therogenic lipoproteins, including VLDL, IDL, LDL, and lipoprotein(a). It reflects the number of potentially harmful lipoprotein particles, making it a strong marker for cardiovascular risk due to obesity.

    Measured: Week 0 (Baseline), Week 8 & Week 16

  8. Change from baseline to the end of the study period in Adiponectin

    Adiponectin is a hormone secreted primarily by adipose (fat) tissue. It plays a crucial role in regulating glucose levels and fatty acid breakdown, contributing to metabolic health. Higher levels of adiponectin are associated with increased insulin sensitivity, anti-inflammatory effects, and reduced risk of cardiovascular disease

    Measured: Week 0 (Baseline), Week 8 & Week 16

  9. Change from baseline to the end of the study period in Ghrelin

    Ghrelin is a hormone primarily produced in the stomach, with smaller amounts secreted by other tissues such as the small intestine, pancreas, and brain. It is often referred to as the "hunger hormone" because it plays a key role in regulating appetite and energy balance. Abnormal ghrelin levels have been associated with conditions like obesity.

    Measured: Week 0 (Baseline), Week 8 & Week 16

  10. Change from baseline to the end of the study period in total glucagon-like peptide 1(GLP- 1)

    Glucagon-like peptide-1 (GLP-1) is an incretin hormone primarily produced in the intestinal L-cells in response to nutrient ingestion. It plays a significant role in glucose metabolism by stimulating insulin secretion, inhibiting glucagon release, slowing gastric emptying. GLP-1 influences weight management primarily by suppressing appetite, slowing gastric emptying, and reducing food intake.

    Measured: Week 0 (Baseline), Week 8 & Week 16

  11. Change from baseline to the end of the study period in C-Peptide

    C-peptide is a short chain of amino acids that is released into the bloodstream as a by-product when insulin is produced by the pancreas. During obesity, C-peptide levels are typically elevated due to increased insulin secretion driven by insulin resistance. Monitoring these levels can help assess β-cell function and the risk of progression to diabetes.

    Measured: Week 0 (Baseline), Week 8 & Week 16

  12. Change from baseline to the end of the study period in Glucagon

    Glucagon is a hormone produced by the alpha cells of the pancreas that primarily functions to increase blood glucose levels by stimulating hepatic glucose production. During weight loss, increased glucagon levels may be beneficial because It promotes the mobilization of stored fat by encouraging lipolysis.it helps maintain blood glucose levels when carbohydrate intake is reduced.

    Measured: Week 0 (Baseline), Week 8 & Week 16

  13. Change from baseline to the end of the study period in VCAM-1

    VACM-1 is a cell surface glycoprotein expressed primarily on vascular endothelial cells in response to inflammatory stimuli. It plays a crucial role in mediating the adhesion and transmigration of leukocytes during inflammatory processes. In obesity, due to chronic low-grade inflammation, pro inflammatory cytokines such as IL-6, TNF-a induce the up regulation of adhesion molecules like VCAM-1 on endothelial cells lining blood vessels in adipose tissue.

    Measured: Week 0 (Baseline), Week 8 & Week 16

  14. Change from baseline to the end of the study period in ICAM- 1

    Day 1 (Baseline), Week 8 \& Week 16

    Measured: ICAM-1 is typically expressed at low levels on various cell types, including endothelial cells (lining blood vessels), immune cells (like leukocytes), and epithelial cells. ICAM-1 expression is significantly upregulated in adipose tissue in obesity.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jul 2025
  2. Study start16 Jul 2025
  3. Primary completion25 Jan 2026 (estimated)
  4. Study completion25 Jan 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07083947
Sponsor's protocol ID
APX/OW/CL24212/25
Status last verified
Nov 2025
First submitted
11 Jul 2025
Last updated
1 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Hall KD, Guo J. Obesity Energetics: Body Weight Regulation and the Effects of Diet Composition. Gastroenterology. 2017 May;152(7):1718-1727.e3. doi: 10.1053/j.gastro.2017.01.052. Epub 2017 Feb 11.

    PubMed 28193517

  • Ng M, Fleming T, Robinson M, Thomson B, Graetz N, Margono C, Mullany EC, Biryukov S, Abbafati C, Abera SF, Abraham JP, Abu-Rmeileh NM, Achoki T, AlBuhairan FS, Alemu ZA, Alfonso R, Ali MK, Ali R, Guzman NA, Ammar W, Anwari P, Banerjee A, Barquera S, Basu S, Bennett DA, Bhutta Z, Blore J, Cabral N, Nonato IC, Chang JC, Chowdhury R, Courville KJ, Criqui MH, Cundiff DK, Dabhadkar KC, Dandona L, Davis A, Dayama A, Dharmaratne SD, Ding EL, Durrani AM, Esteghamati A, Farzadfar F, Fay DF, Feigin VL, Flaxman A, Forouzanfar MH, Goto A, Green MA, Gupta R, Hafezi-Nejad N, Hankey GJ, Harewood HC, Havmoeller R, Hay S, Hernandez L, Husseini A, Idrisov BT, Ikeda N, Islami F, Jahangir E, Jassal SK, Jee SH, Jeffreys M, Jonas JB, Kabagambe EK, Khalifa SE, Kengne AP, Khader YS, Khang YH, Kim D, Kimokoti RW, Kinge JM, Kokubo Y, Kosen S, Kwan G, Lai T, Leinsalu M, Li Y, Liang X, Liu S, Logroscino G, Lotufo PA, Lu Y, Ma J, Mainoo NK, Mensah GA, Merriman TR, Mokdad AH, Moschandreas J, Naghavi M, Naheed A, Nand D, Narayan KM, Nelson EL, Neuhouser ML, Nisar MI, Ohkubo T, Oti SO, Pedroza A, Prabhakaran D, Roy N, Sampson U, Seo H, Sepanlou SG, Shibuya K, Shiri R, Shiue I, Singh GM, Singh JA, Skirbekk V, Stapelberg NJ, Sturua L, Sykes BL, Tobias M, Tran BX, Trasande L, Toyoshima H, van de Vijver S, Vasankari TJ, Veerman JL, Velasquez-Melendez G, Vlassov VV, Vollset SE, Vos T, Wang C, Wang X, Weiderpass E, Werdecker A, Wright JL, Yang YC, Yatsuya H, Yoon J, Yoon SJ, Zhao Y, Zhou M, Zhu S, Lopez AD, Murray CJ, Gakidou E. Global, regional, and national prevalence of overweight and obesity in children and adults during 1980-2013: a systematic analysis for the Global Burden of Disease Study 2013. Lancet. 2014 Aug 30;384(9945):766-81. doi: 10.1016/S0140-6736(14)60460-8. Epub 2014 May 29.

    PubMed 24880830

  • Semlitsch T, Stigler FL, Jeitler K, Horvath K, Siebenhofer A. Management of overweight and obesity in primary care-A systematic overview of international evidence-based guidelines. Obes Rev. 2019 Sep;20(9):1218-1230. doi: 10.1111/obr.12889. Epub 2019 Jul 8.

    PubMed 31286668

Questions about this trial

What is this clinical trial studying?

A study testing CL19183 and CL24212 in people with Healthy Participants, run by ApexCPG LLC at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 1 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline to the end of the study period in Body weight (time frame: Week 0 (Baseline), Week 2, Week 4, Week 8, Week 12 & Week 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07083947, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2025.

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