Prokinetic Effect of Selected Nutraceuticals

Allama Iqbal Open University Islamabad

Status: Completed

Conditions: Pulmonary Tuberculosis; Gastro-Intestinal Disorder

Treatments: Other: Placebo; Dietary Supplement: Zingier officinale powder; Dietary Supplement: Mentha spicata oil; Dietary Supplement: Carum carvi, L powder

Study type: Interventional

Funder types: Other

Identifiers

NCT06157034

Allama Iqbal Open University.

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 200 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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200 participants in 6 patient groups

Exploratory

No Intervention group

Description:

* 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

T1

Experimental group

Description:

* 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.

Treatment:

Other: Placebo

T2

Experimental group

Description:

* 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.

Treatment:

Dietary Supplement: Zingier officinale powder

T3

Experimental group

Description:

* 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.

Treatment:

Dietary Supplement: Carum carvi, L powder

T4

Experimental group

Description:

* 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.

Treatment:

Dietary Supplement: Mentha spicata oil

Washout period

No Intervention group

Description:

* 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.