Prokinetic Effect of Selected Nutraceuticals

Study Overview
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Brief Summary
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Anti-Tuberculosis Treatment (ATT) is one of the effective treatments of tuberculosis but the use of drugs for a long time put an adverse effect on the gut and other organs of the body. Nutraceuticals are the cheapest natural sources with therapeutic effects. These natural medicines help in alleviating gastrointestinal disturbances. This study will be conducted to overcome gastrointestinal issues with the help of nutraceuticals, which are more acceptable by the majority and have no side effects.

Detailed Description
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The aim of this study will be to evaluate if Zingiber officinale, Carum carvi, L, and Mentha spicata L nutraceuticals can help in alleviating gastrointestinal disturbances in subjects which are more acceptable by the majority and have no side effects. This Randomized Control interventional three arms Trial will comprise three phases. Patients will be randomized to Zingiber officinale, Carum carvi, L, and Mentha spicata L nutraceuticals or placebo for three months. We will evaluate symptoms assessment, dietary assessment, biochemical and physical analysis i.e. Acid-Fast Bacillus (AFB) for sputum, Chest X-ray (CXR), and Complete Blood Count (CBC) at baseline and after 3 months since the study started.

Official Title
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Prokinetic Effect of Selected Nutraceuticals on Management of Gastrointestinal Disturbances Among Pulmonary Tuberculosis Patients

Conditions
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Pulmonary Tuberculosis, Gastro-Intestinal Disorder

Intervention / Treatment
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* Other: Placebo
* Dietary Supplement: Zingier officinale powder
* Dietary Supplement: Carum carvi, L powder
* Dietary Supplement: Mentha spicata oil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Newly diagnosed Pulmonary TB patients (both genders) Age group 18-65 years Symptoms criteria (Rome IV) Exclusion Criteria: Patients ˃ 18 years and ˂ 65 years. Patients registered with extra pulmonary disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: Phase1 - 200 population size will be divided into 4 treatment groups Phase2 The phase will check the impact of selected nutraceuticals on TB patients with dietary counseling and all collected data in Phase1 will be repeated at the end 3 selected nutraceuticals Zingiber officinale, Carum carvi, and Mentha spicata will be used against placebo and each placed in a separate group with 50 subjects for 3 months Before dispensing treatments, raw material will be processed and encapsulated in prescribed doses in 4 groups after breakfast and dinner T1-Placebo 100mg/d, T2-Zingiber Officinale powder (500mg 2x/d=1000mg/d), T3-Carum powder(1g 2x/d=2g/d), T4-Mentha oil(2% of oil1.5ml 2x/d=30mg/d) Phase3 - The impact of withholding the intervention will be studied to observe any change in selected parameters
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Exploratory<br>After sampling the study population of 200 will be divided into four (04) treatment groups i.e. T1 (Placebo), T2 (Zingiber officinale), T3 (Carum carvi, L), and T4 (Mentha spicata L). Each group will be allotted 50 subjects | |
| Experimental: T1<br>In the pursuit of scientific understanding, clinical studies play a pivotal role in evaluating the efficacy of treatments. One essential aspect is the inclusion of a placebo group, denoted as the T1 group in this study. Participants in this group will be administered inert material in the form of 100 mg capsules, serving as a baseline for comparison against the active treatment groups. Group Designation: T1 Placebo Group Intervention: 100 mg capsule containing inert material Dosage Frequency: Daily Duration: 3 months Number of Participants: 50 subjects Participants in the T1 Placebo Group are fully informed about the nature of the study, including the possibility of receiving a placebo. Informed consent is obtained from each participant, ensuring that they are aware of the study's objectives and the potential for receiving an inactive treatment. | Other: Placebo<br>* Inert Material<br>|
| Experimental: T2<br>Zingiber officinale, commonly known as ginger, has been of interest for its potential health benefits. In this clinical study, the T2 treatment group is designated to receive Zingiber officinale powder. Intervention Details: Group Designation: T2 Treatment Group Intervention: Zingiber officinale powder Dosage: 500 mg capsules Dosage Frequency: Twice daily Total Daily Dosage: 1000 mg Administration Timing: After breakfast and dinner Duration: 3 months Throughout the study duration, data will be systematically collected from participants in the T3 treatment group. This data may include subjective reports, clinical assessments, and laboratory analyses. | Dietary Supplement: Zingier officinale powder<br>* The raw form of Zingiber officinale will be grounded in powder by manual grinding and will be encapsulated.<br>|
| Experimental: T3<br>Carum carvi, L, commonly known as caraway, is a botanical with a rich history of traditional use. In this clinical study, a treatment group, denoted as T3, is established to investigate the effects of encapsulated Carum carvi, L powder in alleviating the gastrointestinal disturbances among TB patients. Intervention Details: Generic Name: Carum carvi, L powder Dosage Form: Encapsulated Dosage: 1 g per capsule Frequency: Twice daily Total Daily Dosage: 2 g/day Administration Timing: After breakfast and dinner Duration of Treatment: 3 months Throughout the study duration, data will be systematically collected from participants in the T3 treatment group. This data may include subjective reports, clinical assessments, and laboratory analyses. | Dietary Supplement: Carum carvi, L powder<br>* The raw form of Carum carvi, L will be grounded in powder by manual grinding and will be encapsulated.<br>|
| Experimental: T4<br>Mentha spicata L, commonly known as spearmint, is renowned for its aromatic properties and potential health benefits. In this clinical study, a treatment group, designated as T4, is established to explore the effects of encapsulated Mentha spicata oil. Intervention Details: Generic Name: Mentha spicata oil Dosage Form: Encapsulated Concentration: 2% of Spearmint essential oil Dosage: 1.5 ml per capsule Frequency: Twice daily Total Daily Dosage: 30 ml/day Administration Timing: After breakfast and dinner Duration of Treatment: 3 months Throughout the study duration, data will be systematically collected from participants in the T4 treatment group. This data may include subjective reports, clinical assessments, and laboratory analyses. | Dietary Supplement: Mentha spicata oil<br>* Mentha spicata L will be extracted in the form of oil and will be encapsulated.<br>|
| No Intervention: Washout period<br>In this phase impact of withholding the intervention on all parameters will be studied. All parameters included in phase1 and 2 will be repeated after one month accordingly, to observe any change in selected parameters after discontinuation of intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| --GIT disturbances | GIT disturbences will be assessed through ROME IV including abdominal pain, bloating, vomiting and nausea in Phase 1. | 1 Month at study commencement (Phase 1) | 
| GIT disturbances | GIT disturbences will be assessed through ROME IV including abdominal pain, bloating, vomiting and nausea in Phase 2 after completion of three-month intervention. | Termination of Phase 2 (Intervention period) 3 Months | 
| GIT disturbances | GIT disturbences will be assessed through ROME IV including abdominal pain, bloating, vomiting and nausea in Phase 3 which is wash out time. | Termination of phase 3 (Washout period) 1 Month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Mass Index | Measurements will be taken in triplicate. Height will be measured to the nearest 0.5 cm with a stadiometer (or knee height, ulnar length or arm span [demispan] for those persons unable to stand fully erect); body weight will be measured to the nearest 0.1 kg. | through study completion, an average of 9 months | 
| A self-designed / pretested questionnaire | will be used to collect data on other determinants that affect patients regarding disease history, and dietary history. Agarwal Socio-economic status (SES) performa will be used. | through study completion, an average of 9 months | 
| Acid-Fast Bacillus (sputum) | sample will be taken at time of enrollment in study to make diagnosis of Tuberculosis | through study completion, an average of 9 months | 
| Chest X-ray (CXR) | Phase 1 in which subjects will be enrolled and their CXR will be taken as criteria for diagnosis of TB | 1 Day at study commencement (Phase 1) | 
| Complete blood count (CBC) | Phase 1 in which subjects will be enrolled and their CBC will be taken as criteria for diagnosis of TB | 1 Day at study commencement (Phase 1) |