Prokinetic Effect of Selected Nutraceuticals

NCT06157034 | Completed

• 1 other identifier: Allama Iqbal Open University.
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Tuberculosis; Gastro-Intestinal Disorder

Outcome Measures

Primary Outcomes (3)

• --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 Outcomes (5)

• Body Mass Index

  "through study completion, an average of 9 months"

• A self-designed / pretested questionnaire

  "through study completion, an average of 9 months"

• Acid-Fast Bacillus (sputum)

  "through study completion, an average of 9 months"

• Chest X-ray (CXR)

  "1 Day" at study commencement (Phase 1)

• Complete blood count (CBC)

  "1 Day" at study commencement (Phase 1)

Study Arms (6)

Exploratory

NO INTERVENTION

* 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

* 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

T2

EXPERIMENTAL

* 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

T3

EXPERIMENTAL

* 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

T4

EXPERIMENTAL

* 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

Washout period

NO INTERVENTION

* 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.

Interventions

Placebo OTHER

Inert Material

T1

Zingier officinale powder DIETARY_SUPPLEMENT

The raw form of Zingiber officinale will be grounded in powder by manual grinding and will be encapsulated.

T2

Carum carvi, L powder DIETARY_SUPPLEMENT

The raw form of Carum carvi, L will be grounded in powder by manual grinding and will be encapsulated.

T3

Mentha spicata oil DIETARY_SUPPLEMENT

Mentha spicata L will be extracted in the form of oil and will be encapsulated.

T4

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Newly diagnosed Pulmonary TB patients (both genders)
• Age group 18-65 years
• Symptoms criteria (Rome IV)

You may not qualify if:

• Patients ˃ 18 years and ˂ 65 years.
• Patients registered with extra pulmonary disease

Sponsors & Collaborators

• Allama Iqbal Open University Islamabad: lead

Study Sites (1)

Sheikh Zayed Medical / college

Rahim Yar Khan, Punjab Province, 64200, Pakistan

Location

MeSH Terms

Conditions

Tuberculosis, Pulmonary; Digestive System Diseases

Condition Hierarchy (Ancestors)

Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Asma Latif, PhD Scholar

  Sheikh Zaid Medical / college.Rahim Yar Khan.Pakistan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dietician

Model Details: 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

Study Record Dates

• First Submitted: November 1, 2020
• First Posted: December 5, 2023
• Study Start: July 15, 2021
• Primary Completion: February 15, 2022
• Study Completion: March 15, 2022
• Last Updated: December 5, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)