Prokinetic Effect of Selected Nutraceuticals

Pulmonary Tuberculosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06157034
• Other study ID #: Allama Iqbal Open University.
• Status: Completed
• Phase: N/A
• Start date: July 15, 2021
• Est. completion date: March 15, 2022

Study information

• Verified date: December 2023
• Source: Allama Iqbal Open University Islamabad
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: March 15, 2022
• Est. primary completion date: February 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Digestive System Diseases
• Gastro-Intestinal Disorder
• Gastrointestinal Diseases
• Intestinal Diseases
• Pulmonary Tuberculosis
• Tuberculosis
• Tuberculosis, Pulmonary

Intervention

Other:
• Placebo
Inert Material

Dietary Supplement:
• Zingier officinale powder
The raw form of Zingiber officinale will be grounded in powder by manual grinding and will be encapsulated.
• Carum carvi, L powder
The raw form of Carum carvi, L will be grounded in powder by manual grinding and will be encapsulated.
• Mentha spicata oil
Mentha spicata L will be extracted in the form of oil and will be encapsulated.

Locations

Country	Name	City	State
Pakistan	Sheikh Zayed Medical / college	Rahim Yar Khan	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Allama Iqbal Open University Islamabad

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	--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)
Primary	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"
Primary	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	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"
Secondary	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"
Secondary	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"
Secondary	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)
Secondary	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)