Pulmonary TuberculosisNCT06157034
Prokinetic Effect of Selected Nutraceuticals
A study testing Zingier officinale powder, Carum carvi, L powder and Mentha spicata oil in people with Pulmonary Tuberculosis and Gastro-Intestinal Disorder, run by Allama Iqbal Open University Islamabad at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pulmonary Tuberculosis, Gastro-Intestinal Disorder
- What is being tested?
- Zingier officinale powder, Carum carvi, L powder and Mentha spicata oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jul 2021to 15 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed Pulmonary TB patients (both genders)
- Age group 18-65 years
- Symptoms criteria (Rome IV)
Who cannot join
- Patients ˃ 18 years and ˂ 65 years.
- Patients registered with extra pulmonary disease
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Sheikh Zayed Medical / college
Rahim Yar Khan, Punjab Province, 64200
About this study
Official title: Prokinetic Effect of Selected Nutraceuticals on Management of Gastrointestinal Disturbances Among Pulmonary Tuberculosis Patients
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.
Read the 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.
- Conditions
- Pulmonary Tuberculosis, Gastro-Intestinal Disorder
- Being tested
- Placebo, Zingier officinale powder, Carum carvi, L powder, Mentha spicata oil
- Medical subject headings
- Tuberculosis, Pulmonary, Digestive System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
Inert Material
Zingier officinale powderDietary supplement
The raw form of Zingiber officinale will be grounded in powder by manual grinding and will be encapsulated.
Carum carvi, L powderDietary supplement
The raw form of Carum carvi, L will be grounded in powder by manual grinding and will be encapsulated.
Mentha spicata oilDietary supplement
Mentha spicata L will be extracted in the form of oil and will be encapsulated.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
--GIT disturbances
GIT disturbences will be assessed through ROME IV including abdominal pain, bloating, vomiting and nausea in Phase 1.
Measured: "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.
Measured: 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.
Measured: Termination of phase 3 (Washout period) "1 Month"
Secondary outcomes (5)
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.
Measured: "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.
Measured: "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
Measured: "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
Measured: "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
Measured: "1 Day" at study commencement (Phase 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2023
- Study start15 Jul 2021
- Primary completion15 Feb 2022
- Study completion15 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- 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)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allama Iqbal Open University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asma Latif, Allama Iqbal Open University Islamabad
- Investigators
- Asma Latif, PhD Scholar, Principal investigator, Sheikh Zaid Medical / college.Rahim Yar Khan.Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06157034
- Sponsor's protocol ID
- Allama Iqbal Open University.
- Status last verified
- Dec 2023
- First submitted
- 1 Nov 2020
- Last updated
- 5 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prokinetic Effect of Selected Nutraceuticals on Management of Gastrointestinal Disturbances Among Pulmonary Tuberculosis Patients
- ClinicalTrials.gov ID
- NCT06157034
- Acronym / sponsor ID
- Allama Iqbal Open University.
- Conditions
- Pulmonary Tuberculosis, Gastro-Intestinal Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Allama Iqbal Open University IslamabadUniversity, hospital or other
- Study start
- 15 Jul 2021 (actual)
- Primary completion
- 15 Feb 2022 (actual)
- Study completion
- 15 Mar 2022 (actual)
- First posted
- 5 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 6
- 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
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: 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. |
| T2 | Experimental | Dietary Supplement: 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. |
| T3 | Experimental | Dietary Supplement: 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 | Experimental | Dietary Supplement: 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. |
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Newly diagnosed Pulmonary TB patients (both genders)
- Age group 18-65 years
- Symptoms criteria (Rome IV)
Key exclusion criteria (2 listed)
- Patients ˃ 18 years and ˂ 65 years.
- Patients registered with extra pulmonary disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboInert Material | Other | T1 |
| Zingier officinale powderThe raw form of Zingiber officinale will be grounded in powder by manual grinding and will be encapsulated. | Dietary supplement | T2 |
| Carum carvi, L powderThe raw form of Carum carvi, L will be grounded in powder by manual grinding and will be encapsulated. | Dietary supplement | T3 |
| Mentha spicata oilMentha spicata L will be extracted in the form of oil and will be encapsulated. | Dietary supplement | T4 |
Primary outcome
--GIT disturbances
Time frame: "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
Time frame: Termination of Phase 2 (Intervention period) "3 Months"
GIT disturbences will be assessed through ROME IV including abdominal pain, bloating, vomiting and nausea in Phase 2 after completion of three-month intervention.
GIT disturbances
Time frame: 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.
5 secondary outcomes
Body Mass Index
Time frame: "through study completion, an average of 9 months"
A self-designed / pretested questionnaire
Time frame: "through study completion, an average of 9 months"
Acid-Fast Bacillus (sputum)
Time frame: "through study completion, an average of 9 months"
Chest X-ray (CXR)
Time frame: "1 Day" at study commencement (Phase 1)
Complete blood count (CBC)
Time frame: "1 Day" at study commencement (Phase 1)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Asma Latif, PhD Scholar principal investigator
Sheikh Zaid Medical / college.Rahim Yar Khan.Pakistan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zingier officinale powder, Carum carvi, L powder and Mentha spicata oil in people with Pulmonary Tuberculosis and Gastro-Intestinal Disorder, run by Allama Iqbal Open University Islamabad at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
--GIT disturbances (time frame: "1 Month" at study commencement (Phase 1)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2023.