An interventional study of Investigational product (IP): Natural orange extract and Group II: Placebo: Microcrystalline cellulose (MCC) in Gut Health, sponsored by Vedic Lifesciences Pvt. Ltd.. Not yet recruiting at 3 sites in India. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-26.
Sponsored by Vedic Lifesciences Pvt. Ltd. · Not applicable, Interventional, and Treatment
A Randomized, Double-Blind, Two-Arm, Placebo-Controlled Clinical Study to assess the Effect of the Natural Orange Extract in Individuals with Gastrointestinal Discomfort
A Randomized, Double-Blind, Two-Arm, Placebo-Controlled Clinical Study to assess the Effect of the Natural Orange Extract in Individuals with Gastrointestinal Discomfort
Vedic Lifesciences Pvt. Ltd. is the lead sponsor of 72 studies on the registry; 8 are open to participants now.
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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.
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.
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.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
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.
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.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
One capsule to be taken with breakfast orally once a day
Dietary Supplement: Investigational product (IP): Natural orange extract
One capsule to be taken with breakfast orally once a day
Dietary Supplement: Group II: Placebo: Microcrystalline cellulose (MCC)
Strength: 500 mg Dose regimen: One capsule to be taken with breakfast orally once a day
Strength: 500 mg Dose regimen: One capsule to be taken with breakfast orally once a day
To assess the effect of the IP on gastrointestinal digestion symptoms as assessed by the change in digestive domain scores of the Gastrointestinal Quality of Life Index (GIQLI) compared to baseline and placebo.
GIQLI is a validated tool suitable for assessing health-related quality of life (QOL) in clinical studies of individuals with gastrointestinal conditions and in routine clinical settings. It evaluates both generic and specific upper and lower gastrointestinal symptoms through 36 items. These questions are grouped into five domains: core symptoms (10 items), physical items (6 items), psychological items (6 items), social items (2 items) and disease-specific items (8 items). The GIQLI total cumulative score for the digestive domain ranges from 0 to 72, with higher scores indicating better gastrointestinal function and quality of life in the context of digestive symptoms
Time frame: Day 0, Day 45, Day 90.
To assess the effect of IP on the following compared to baseline and placebo Gastrointestinal quality of Life as assessed by GIQLI
GIQLI is a validated tool suitable for assessing health-related quality of life (QOL) in clinical studies of individuals with gastrointestinal conditions and in routine clinical settings. It evaluates both generic and specific upper and lower gastrointestinal symptoms through 36 items. These questions are grouped into five domains: core symptoms (10 items), physical items (6 items), psychological items (6 items), social items (2 items) and disease-specific items (8 items). The GIQLI total cumulative score for the digestive domain ranges from 0 to 72, with higher scores indicating better gastrointestinal function and quality of life in the context of digestive symptoms
Time frame: Day 0, Day 45, Day 90
To assess the effect of IP on the following compared to baseline and placebo Stool consistency as assessed by the Bristol Stool Form Scale (BSFS)
The Bristol Stool Form Scale (BSFS) is a 7-point ordinal scale of stool types extensively used in clinical and research settings that classify feces into seven groups
Time frame: Day 0, Day 45, Day 90
To assess the effect of IP on the following compared to baseline and placebo on Percentage responders as assessed by the change in the frequency of BSFS stool types 6 & 7
The Bristol Stool Form Scale (BSFS) is a 7-point ordinal scale of stool types extensively used in clinical and research settings that classify feces into seven groups
Time frame: Day 0, Day 45, Day 90
To assess the effect of IP on the following compared to baseline and placebo on Gastrointestinal symptoms as assessed by the Gastrointestinal Symptoms Rating scale (GSRS)
The GSRS is a self-reported questionnaire for GI discomfort. The questions in this scale ask about the severity of a wide range of gastrointestinal symptoms of an individual during the past week. Questions are to be rated on a Likert scale ranging from no discomfort at all (0) to very severe discomfort (3). A total score is calculated by summing the ratings provided on all questions
Time frame: Day 0, Day 45, Day 90
To assess the effect of IP on the compared to baseline and placebo Intestinal permeability as assessed by serum levels of Lipopolysaccharide binding protein (LBP)
LPS is detected throughout the body by a specific protein called Lipopolysaccharide binding protein (LBP). LBP then initiates the immune response by presenting LPS to cell surface pattern recognition receptors membrane-bound CD14 (mCDC14) and toll-like receptor-4 (TLR4).
Time frame: Day 0 & Day 90
To assess the effect of IP on the compared to baseline and placebo on Inflammation as assessed by Interleukin-6 (IL-6), Interleukin-10 (IL-10) and Tumor Necrosis Factor-alpha (TNF-α)
Inflammation serves as a natural defensive reaction of the innate immune system triggered by various harmful agents such as microorganisms, trauma, necrosis, chemicals, immune responses, or metabolic stress. The acceptable ranges proposed are as follows: IL-6 (Not detectable to 50 pg/ml), IL-10 (Not detectable to 8 pg/ml), and TNF-α (2 to 20 pg/ml)
Time frame: Day 0 & Day 90
To assess the effect of IP on the compared to baseline and placebo on Intestinal inflammation as assessed by fecal calprotectin.
The fecal calprotectin a highly sensitive marker for detecting inflammation associated with GI disorders. The concentration of fecal calprotectin correlates well with the severity of intestinal inflammation,The fecal calprotectin range was found to be 18-37 μg /g in IBS individuals
Time frame: Day 0 & Day 90
To assess the effect of IP on the compared to baseline and placebo on Microbial metabolic activity as assessed by fecal short-chain fatty acids (SCFA) [Acetate, Butyrate and Propionate]
SCFAs exert beneficial effects on gut health through various mechanisms. They help maintain intestinal barrier integrity, promote mucus production, and possess anti-inflammatory properties, thereby contributing to overall GI well-being. These SCFAs range from 20 to 140 mM in the gut, with higher concentrations found in the proximal colon (70-140 mM) and lower concentrations in the distal colon (20-70 mM) and distal ileum (20-40 mM).
Time frame: Day 0 & Day 90
To assess the effect of IP on the compared to baseline and placebo on The gut microbiome as assessed by Next Generation Sequencing (NGS)
NGS allows for a more comprehensive analysis of complex microbial communities compared to traditional culture-based methods. The declining costs associated with NGS have further propelled its widespread adoption in microbiome research. NGS has proven particularly advantageous in elucidating the intricate relationship between the microbiome and various conditions.NGS will be assessed on day 0 and day 90
Time frame: Day 0 & Day 90
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Oct 2024; primary completion for Jan 2025, 3 months later.
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This study is not yet recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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