Dyspepsia ChronicEfficacyNCT06958952
Evaluating the Efficacy of "Digestive Aid" in Functional Dyspepsia
A study testing Digestive Aid in people with Dyspepsia Chronic, run by Tehran University of Medical Sciences at 1 site in Iran.
Trial summary
Functional Dyspepsia (FD) is diagnosed in the presence of bothersome epigastric pain or burning, early satiation and/or postprandial fullness of greater than 8 weeks duration, in the absence of alarm signs. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Dyspepsia Chronic
- What is being tested?
- Digestive Aid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteIran
- Study dates
- 15 Apr 2025to Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The new onset dyspeptic patients
Who cannot join
- Participants with co-morbidities (known GI diseases)
- Taking medications,
- Those with abnormal gastrointestinal findings in physical examination and para-clinical investigations
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Iran1 site, 1 recruiting
- Recruiting
Sina Hospital
Tehran
Raika Jamali, +98-21-63120000, jamalira@tums.ac.ir
Jamali
About this study
Official title: Evaluating the Efficacy of "Digestive Aid" in Functional Dyspepsia: A Randomized Double Blind Control Trial
Functional Dyspepsia (FD) is diagnosed in the presence of bothersome epigastric pain or burning, early satiation and/or postprandial fullness of greater than 8 weeks duration, in the absence of alarm signs. Alarm signs include weight loss, gastrointestinal bleeding, anemia, dysphagia, and family history of upper gastrointestinal malignancies. FD is a common gastrointestinal complaint. It's prevalence in Iranian population is reported to be from 2.2% to 29.9% (1). FD should be introduced as a disorder of gut-brain interaction (DGBI), together with a simple account of the gut-brain axis and how this is impacted by diet, stress, cognitive, behavioral and emotional responses to symptoms and post-infective changes. Histamine-2-receptor antagonists, proton pump inhibitors, and prokinetics are introduced as the first line classic treatment in FD. (2) Tricyclic antidepressants (TCAs) used as gut-brain neuromodulators are an efficacious second-line treatment for FD. (2) Antipsychotics, such as sulpiride 100 mg four times a day or levosulpiride 25 mg three times a day, may be efficacious as a second-line treatment for FD. Tandospirone, Pregabalin, Mirtazapine are among the suggested second line pharmachological therapy. (2) FD expresses a spectrum of various upper gastrointestinal complaints. Epigastric pain, retrosternal pain, regurgitation, nausea, vomiting, belching, dysphagia, and early satiety are among the most frequent symptoms. Therefore, a combination of medications might be needed to alleviate the patients' discomfort. The pharmaceutics have proposed the package of medications to increase the patient compliance. "Digestive Aid" is a cocktail that contains Marshmallow, Ginger, Gentian, Fennel, Peppermint, and Anise oil. It is widely used by physicians to control dyspeptic symptoms. There are studies on human and animals that showed the efficacy of mentioned herbal supplements on dyspepsia. To the best of our knowledge there is no study about the efficacy of "Digestive Aid" in the dyspeptic patients. This trial is conducted to evaluate the efficacy of mentioned product in alleviating the symptoms in FD in a sample of the Iranian patients.
Read the detailed description
This double blind placebo-control clinical trial is performed in dyspeptic patients referred to the gastroenterology clinic in Sina Hospital. Neither the participants nor the researcher knows which treatment or intervention are provided until the end of trial. The new onset dyspeptic patients that are older than 18 years of age will be included in the project. The gastroenterologist diagnose FD after taking the complete medical history, physical examination, laboratory investigations and performing upper gastrointestinal endoscopy. Participants with co-morbidities (known GI diseases), taking medications, those with abnormal gastrointestinal findings in physical examination and para-clinical investigations will be excluded from the research. FD will be diagnosed based on the Rome 4 criteria.
Participants will fill out an informed written consent prior to the enrollment. The trial has two arms. The patients in case group receive the film-coated "Digestive Aid" product once daily for 2 months. The control group takes the placebo for the same duration. Both products are manufactured by Darman Yab Darou Incorporation, Tehran, Iran. The caregiver who gives the medication to the participants is blind to the type of capsules. Block Randomization will be used to assign the participants to intervention or placebo group considering their age and gender.
The efficacy of medication on the severity of symptom is evaluated by the valid Persian version of the "Leeds dyspepsia questionnaire" (LDQ).(3) This questionnaire evaluates 8 dyspeptic complaints. Epigastric pain, retrosternal pain, regurgitation, nausea, vomiting, belching, dysphagia, and early satiety are the key elements that are evaluated in this questionnaire. The severity of symptoms are graded from 0 to 8. The sum of scores in all 8 items of the questionnaire represents the patients' total score. The Primary outcome measure is defining the changes of dyspeptic symptoms from baseline to the end of treatment.
A statistical power analysis is used to calculate the sample size. Considering the two-sided significant level (α) of 0.05 and the power of 90% (β = 0.1), a total sample size of 46 patients is determined to detect one percent inter-group difference in LDQ score. (For detailed information, please refer to http://hedwig.mgh.harvard.edu/sample_size/js/js_parallel_quant.html). To allow for a 5% possible dropout rate, 50 patients will be recruited in the trial.
Analysis of covariance (ANCOVA) will be applied for comparing treatment groups regarding the changes of variables during the study. All statistical analyses will be performed using SPSS version 17 (SPSS, Chicago, IL, The USA). The probability of the difference between the dependent and independent variables is considered significant if a two-tailed P value is less than 0.05.
- Conditions
- Dyspepsia Chronic
- Being tested
- Digestive Aid, Placebo
- Keywords
- Efficacy, Clinical trial, Functional Dyspepsia, questionnaire, Digestive Aid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digestive AidDietary supplement
one tablet daily for one month
PlaceboDietary supplement
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Digestive Aid | Experimental | Treatment with Digestive Aid Receives: Dietary Supplement: Digestive Aid |
| Placebo | Placebo comparator | Treatment with placebo Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Dyspepsia
Functional Dyspepsia evaluation based on the Leeds Dyspepsia Questionnaire (LDQ)
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2025
- Study start15 Apr 2025
- Primary completion30 Dec 2025 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Dyspepsia ChronicStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Darman Yab Darou Co.
- Responsible party
- Principal investigator, Raika Jamali, MD, Tehran University of Medical Sciences
- Investigators
- Raika Jamali, M.D., Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06958952
- Sponsor's protocol ID
- 1403-4-101-75896
- Other IDs
- 1403-4-101-75896
- Acronym
- Efficacy
- Status last verified
- Apr 2025
- First submitted
- 7 Mar 2025
- Last updated
- 6 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All the data
Publications
Amini E, Keshteli AH, Jazi MS, Jahangiri P, Adibi P. Dyspepsia in Iran: SEPAHAN Systematic Review No. 3. Int J Prev Med. 2012 Mar;3(Suppl 1):S18-25.
PubMed 22826763Narendren A, Boddupalli S, Segal JP. British Society of Gastroenterology guidelines on the management of functional dyspepsia. Frontline Gastroenterol. 2023 Oct 11;15(1):70-73. doi: 10.1136/flgastro-2023-102508. eCollection 2024 Jan.
PubMed 38487566Batebi S, Masjedi Arani A, Jafari M, Sadeghi A, Saberi Isfeedvajani M, Davazdah Emami MH. Validity and Reliability of the Persian Version of Leeds Dyspepsia Questionnaire. Galen Med J. 2019 Dec 31;8:e1609. doi: 10.31661/gmj.v8i0.1609. eCollection 2019.
PubMed 34466536
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy of "Digestive Aid" in Functional Dyspepsia: A Randomized Double Blind Control Trial
- ClinicalTrials.gov ID
- NCT06958952
- Acronym / sponsor ID
- Efficacy / 1403-4-101-75896
- Conditions
- Dyspepsia Chronic
- Keywords
- Efficacy, Clinical trial, Functional Dyspepsia, questionnaire, Digestive Aid
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Collaborators
- Darman Yab Darou Co.
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 6 May 2025 (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.
Functional Dyspepsia (FD) is diagnosed in the presence of bothersome epigastric pain or burning, early satiation and/or postprandial fullness of greater than 8 weeks duration, in the absence of alarm signs. Alarm signs include weight loss, gastrointestinal bleeding, anemia, dysphagia, and family history of upper gastrointestinal malignancies. FD is a common gastrointestinal complaint. It's prevalence in Iranian population is reported to be from 2.2% to 29.9% (1). FD should be introduced as a disorder of gut-brain interaction (DGBI), together with a simple account of the gut-brain axis and how this is impacted by diet, stress, cognitive, behavioral and emotional responses to symptoms and post-infective changes. Histamine-2-receptor antagonists, proton pump inhibitors, and prokinetics are introduced as the first line classic treatment in FD. (2) Tricyclic antidepressants (TCAs) used as gut-brain neuromodulators are an efficacious second-line treatment for FD. (2) Antipsychotics, such as sulpiride 100 mg four times a day or levosulpiride 25 mg three times a day, may be efficacious as a second-line treatment for FD. Tandospirone, Pregabalin, Mirtazapine are among the suggested second line pharmachological therapy. (2) FD expresses a spectrum of various upper gastrointestinal complaints. Epigastric pain, retrosternal pain, regurgitation, nausea, vomiting, belching, dysphagia, and early satiety are among the most frequent symptoms. Therefore, a combination of medications might be needed to alleviate the patients' discomfort. The pharmaceutics have proposed the package of medications to increase the patient compliance. "Digestive Aid" is a cocktail that contains Marshmallow, Ginger, Gentian, Fennel, Peppermint, and Anise oil. It is widely used by physicians to control dyspeptic symptoms. There are studies on human and animals that showed the efficacy of mentioned herbal supplements on dyspepsia. To the best of our knowledge there is no study about the efficacy of "Digestive Aid" in the dyspeptic patients. This trial is conducted to evaluate the efficacy of mentioned product in alleviating the symptoms in FD in a sample of the Iranian patients.
Detailed description
This double blind placebo-control clinical trial is performed in dyspeptic patients referred to the gastroenterology clinic in Sina Hospital. Neither the participants nor the researcher knows which treatment or intervention are provided until the end of trial. The new onset dyspeptic patients that are older than 18 years of age will be included in the project. The gastroenterologist diagnose FD after taking the complete medical history, physical examination, laboratory investigations and performing upper gastrointestinal endoscopy. Participants with co-morbidities (known GI diseases), taking medications, those with abnormal gastrointestinal findings in physical examination and para-clinical investigations will be excluded from the research. FD will be diagnosed based on the Rome 4 criteria.
Participants will fill out an informed written consent prior to the enrollment. The trial has two arms. The patients in case group receive the film-coated "Digestive Aid" product once daily for 2 months. The control group takes the placebo for the same duration. Both products are manufactured by Darman Yab Darou Incorporation, Tehran, Iran. The caregiver who gives the medication to the participants is blind to the type of capsules. Block Randomization will be used to assign the participants to intervention or placebo group considering their age and gender.
The efficacy of medication on the severity of symptom is evaluated by the valid Persian version of the "Leeds dyspepsia questionnaire" (LDQ).(3) This questionnaire evaluates 8 dyspeptic complaints. Epigastric pain, retrosternal pain, regurgitation, nausea, vomiting, belching, dysphagia, and early satiety are the key elements that are evaluated in this questionnaire. The severity of symptoms are graded from 0 to 8. The sum of scores in all 8 items of the questionnaire represents the patients' total score. The Primary outcome measure is defining the changes of dyspeptic symptoms from baseline to the end of treatment.
A statistical power analysis is used to calculate the sample size. Considering the two-sided significant level (α) of 0.05 and the power of 90% (β = 0.1), a total sample size of 46 patients is determined to detect one percent inter-group difference in LDQ score. (For detailed information, please refer to http://hedwig.mgh.harvard.edu/sample_size/js/js_parallel_quant.html). To allow for a 5% possible dropout rate, 50 patients will be recruited in the trial.
Analysis of covariance (ANCOVA) will be applied for comparing treatment groups regarding the changes of variables during the study. All statistical analyses will be performed using SPSS version 17 (SPSS, Chicago, IL, The USA). The probability of the difference between the dependent and independent variables is considered significant if a two-tailed P value is less than 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digestive Aid | Experimental | Dietary Supplement: Digestive AidTreatment with Digestive Aid |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboTreatment with placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The new onset dyspeptic patients
Key exclusion criteria (3 listed)
- Participants with co-morbidities (known GI diseases)
- Taking medications,
- Those with abnormal gastrointestinal findings in physical examination and para-clinical investigations
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 |
|---|---|---|
| Digestive Aidone tablet daily for one month | Dietary supplement | Digestive Aid |
| PlaceboPlacebo | Dietary supplement | Placebo |
Primary outcome
Functional Dyspepsia
Time frame: One month
Functional Dyspepsia evaluation based on the Leeds Dyspepsia Questionnaire (LDQ)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2025.
- Results publication: PubMed 22826763Amini E, Keshteli AH, Jazi MS, Jahangiri P, Adibi P. Dyspepsia in Iran: SEPAHAN Systematic Review No. 3. Int J Prev Med. 2012 Mar;3(Suppl 1):S18-25.
- Results publication: PubMed 38487566Narendren A, Boddupalli S, Segal JP. British Society of Gastroenterology guidelines on the management of functional dyspepsia. Frontline Gastroenterol. 2023 Oct 11;15(1):70-73. doi: 10.1136/flgastro-2023-102508. eCollection 2024 Jan.
- Results publication: PubMed 34466536Batebi S, Masjedi Arani A, Jafari M, Sadeghi A, Saberi Isfeedvajani M, Davazdah Emami MH. Validity and Reliability of the Persian Version of Leeds Dyspepsia Questionnaire. Galen Med J. 2019 Dec 31;8:e1609. doi: 10.31661/gmj.v8i0.1609. eCollection 2019.
- Individual participant dataSharing planned: Yes. All the data
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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.
Raika Jamali, M.D. principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digestive Aid in people with Dyspepsia Chronic, run by Tehran University of Medical Sciences at 1 site in Iran.
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 1 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 6 May 2025. 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 Iran. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Raika Jamali, Professor (+98-21-63120000, jamalira@tums.ac.ir), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Dyspepsia (time frame: One month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06958952, which also lists 3 linked publications.
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 6 May 2025.