Prokinetic Effect of Selected Nutraceuticals

Not Applicable

Completed

• Conditions: Pulmonary Tuberculosis; Gastro-Intestinal Disorder
• Interventions: Other: Placebo; Dietary Supplement: Carum carvi, L powder; Dietary Supplement: Mentha spicata oil; Dietary Supplement: Zingier officinale powder

• Registration Number: NCT06157034
• Lead Sponsor: Allama Iqbal Open University Islamabad

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2020-11-01
• Study Start: 2021-07-15
• Primary Completion: 2022-02-15
• Study Completion: 2022-03-15
• Status Verified: 2023-12
• Study First Submitted QC: 2023-12-03
• Last Update Submitted: 2023-12-03
• Study First Posted: 2023-12-05
• Last Update Posted: 2023-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
T1	Placebo	* 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.
T3	Carum carvi, L powder	* 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.
T4	Mentha spicata oil	* 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.
T2	Zingier officinale powder	* 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.

Primary Outcome Measures

Name	Time	Method
--GIT disturbances	"1 Month" at study commencement (Phase 1)	GIT disturbences will be assessed through ROME IV including abdominal pain, bloating, vomiting and nausea in Phase 1.
GIT disturbances	Termination of phase 3 (Washout period) "1 Month"	GIT disturbences will be assessed through ROME IV including abdominal pain, bloating, vomiting and nausea in Phase 3 which is wash out time.

Secondary Outcome Measures

Name	Time	Method
A self-designed / pretested questionnaire	"through study completion, an average of 9 months"	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.
Complete blood count (CBC)	"1 Day" at study commencement (Phase 1)	Phase 1 in which subjects will be enrolled and their CBC will be taken as criteria for diagnosis of TB
Body Mass Index	"through study completion, an average of 9 months"	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.
Chest X-ray (CXR)	"1 Day" at study commencement (Phase 1)	Phase 1 in which subjects will be enrolled and their CXR will be taken as criteria for diagnosis of TB
Acid-Fast Bacillus (sputum)	"through study completion, an average of 9 months"	sample will be taken at time of enrollment in study to make diagnosis of Tuberculosis

Trial Locations

Locations (1)

Sheikh Zayed Medical / college; 🇵🇰 Rahim Yar Khan, Punjab, Pakistan