Electrolyte DisturbanceNCT05245019
Effects of Cardamom and Fennel on Salivary pH and Anti Microbial Activity
A study testing cardamom and fennel in people with Electrolyte Disturbance and Saliva Altered, run by University of Karachi at 1 site in Pakistan.
Trial summary
Dental caries is the most prevalent infectious disease related to oral health.. Although significant advances have been made on a global front to prevent caries, studies show its incidence is on the rise making it one of the major chronic diseases affecting all age groups. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Electrolyte Disturbance, Saliva Altered
- What is being tested?
- cardamom and fennel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Feb 2022to 31 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Completely dentate individuals
- Males \& Females Patients ≥ 18 years
- Individuals not undergoing topical fluoride therapy, other chemotherapeutic procedures, antibiotics, and drugs having an effect upon the salivary function or salivary pH
- Individuals not suffering from any systemic diseases/ taking any medication that affects the salivary secretion
Who cannot join
- Patients suffering from systemic diseases
- Patients taking drugs that can effect ph. of saliva
- Patients less then18 years of age -
Trial locations and contacts
1 site in 1 country.
About this study
Dental caries is the most prevalent infectious disease related to oral health.. Although significant advances have been made on a global front to prevent caries, studies show its incidence is on the rise making it one of the major chronic diseases affecting all age groups. It possesses not only a great load concerning cost on developed nations but an increasing burden on developing nations. It largely affects children and the lower socioeconomic group hence demanding feasible and inexpensive ways to counter this growing ailment.
Dental caries is a multifactorial disease involving the interaction of the host, agent, and the environment. The primary etiologic agent implicated in dental caries is the streptococcus mutans and non-streptococcus species like Lactobacillus, Actinomyces, and Veillonella species. These oral microbes break down carbohydrates content in the diet, producing acids as by-products. The acids produced lower the pH of plaque and saliva resulting in the demineralization of enamel and dentine, finally enhancing the formation of cavities or dental caries.
Read more
The role of saliva in maintaining oral health has been studied extensively over time. The buffering capacity of saliva prevents the teeth from demineralization by maintaining the pH of the oral cavity thereby reducing the risk of dental caries. Since ancient times, medicinal plants and herbs have been used for maintaining oral health. Recent studies have shown fennel seeds and cardamom to play a significant role in regulating the pH of saliva and plaque, and ultimately preventing dental caries.
Cardamom (Elettaria cardamomum) is used as a flavoring agent in foods as well as for treating various cardiovascular, gastrointestinal, and neural problems. In addition, its extracts have shown antimicrobial activity against the principal pathogens causing dental caries and oral candidiasis. The commonest are S. mutans and Lactobacillus.
Fennel (Foeniculum vulgare) is a dry seed used in treating various ailments. Known for its anti-inflammatory, anti-spasmodic, and analgesic properties, it is also widely used for treating gastroenteritis and indigestion. Over time, it has been used in many oral care products for its antiseptic properties and as a breath freshener on its own. Studies have found fennel to not only inhibit the activity of streptococcus Mutans but also cause a significant rise in salivary pH hence depicting the anti-cariogenic activity.
Given the above literature, this study has been designed to record the effects of cardamom and fennel on the salivary pH and their anti-microbial activity on selected microbial species in our population.
Read the detailed description
This study has been designed to evaluate the effects of cardamom and fennel on oral pH and microbes of the oral cavity.
OBJECTIVES OF THE STUDY:
- To compare the change in pH of the saliva before and after Cardamom use
- To compare the change in pH of the saliva before and after Fennel use
- To compare the pH changes after fennel and cardamom use on patients' saliva
- To evaluate the effects of Cardamom extract on oral pathogens (S. mutans and Lactobacillus)
- To evaluate the effects of Fennel extract on oral pathogens
- To compare the effects of Cardamom and Fennel extract on oral pathogens.
STUDY DESIGN:
Randomized clinical trial
INCLUSION CRITERIA:
- Completely dentate individuals
- Males \& Females Patients ≥ 18 years
- Individuals not undergoing topical fluoride therapy, other chemotherapeutic procedures, antibiotics, and drugs affecting the salivary function or salivary pH
- Individuals not suffering from any systemic diseases/ taking any medication that affects salivary secretion (14).
METHODOLOGY:
Patients coming to the dental setting for a dental checkup or dental procedures, after written informed consent will be enrolled in the study. They will be requested not to take anything orally except plain water for an hour. After an hour they will be required to give salivary samples as control first (control salivary samples). pH will be measured of provided salivary samples with a portable digital pH meter.
Afterward, divided randomly into groups A with a minimum of 25 patients will be given Cardamom (one pod). The second group, Group B will be given Fennel (half teaspoon full, 1.3 grams) to be chewed for 10 minutes under the supervision of the researcher. The saliva will again be collected in clean containers and pH will be assessed.
For the second part of the study, the extract will be prepared with ten grams of fruit powder to be kept in 70% methanol (100ml) for 3 days, followed by filtration and proper storage. Bacteria will be grown from control salivary samples on the required agars. With micro-pathological techniques and expertise, the extract will be applied to the agar and the zone of inhibition will be measured in millimeters on inoculated agar plates with the agar well diffusion method. Standard strains as control will be taken from DDRL Lab. For positive control, Tablet Ciprofloxacin will be used. (12).
Data collected will be evaluated statistically using SPSS 26. For numerical values, mean with standard deviation, and for categorical values percentages will be calculated. To compare before and after paired T-test and to compare between the two treatments, students' T-test will be applied. A value equal to and greater than 0.05 will be considered significant.
- Conditions
- Electrolyte Disturbance, Saliva Altered
- Being tested
- cardamom, fennel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardamomBiological
Also called Elettaria cardamomum
cardamom is used as a flavoring agent in foods as well as for treating various cardiovascular, gastrointestinal, and neural problems
fennelBiological
Also called Foeniculum vulgare
fennel is Known for its anti-inflammatory, anti-spasmodic, and analgesic properties, it is also widely used for treating gastroenteritis and indigestion.
| Study group | Role | What they receive |
|---|---|---|
| cardamom group | Experimental | the pH of saliva will be checked first then they r required to chew cardamom nd after 15 minutes again pH will be checked Receives: Biological: cardamom |
| fennel group | Experimental | the pH of saliva will be checked first then they r required to chew fennel and after 15 minutes again pH will be checked Receives: Biological: fennel |
What is being measured
The primary outcome is the main question the study is designed to answer.
salivary pH
Change in pH will be observed before and after cardamom and fennel chewing
Measured: 1 Month
Secondary outcomes (1)
anti-microbial activity
Anti-microbial activity of common oral pathogens will be assessed in vitro. The prepared extract will be applied on oral bacteria (Streptococcus mutans and Lactobacillus) grown on agar plates. After incubation, the zone of inhibition will be measured in millimeters with a measuring scale on inoculated agar plates with the agar well diffusion method. the collected measurements will be assessed for a maximum zone of inhibition in millimeters.
Measured: 1 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2022
- Study start1 Feb 2022
- Primary completion28 Mar 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Electrolyte DisturbanceStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Males \& Females Patients ≥ 18 years Individuals not undergoing topical fluoride therapy, other chemotherapeutic procedures, antibiotics, and drugs having an effect upon the salivary function or salivary pH Individuals not suffering from any systemic diseases/ taking any medication that affects salivary secretion
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Karachi
- Sponsor type
- University, hospital or other
- Collaborators
- Altamash Institute of Dental Medicine
- Responsible party
- Principal investigator, Dr Rabia Arshad, Altamash Institute of Dental Medicine
- Investigators
- RABIA ARSHAD, Ph.D, Principal investigator, ALTAMASH INSTITUTE OF DENTAL MEDICINE, KARACHI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05245019
- Sponsor's protocol ID
- AIDM
- Status last verified
- May 2022
- First submitted
- 25 Jan 2022
- Last updated
- 24 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Manohar R, Ganesh A, Abbyramy N, Abinaya R, Balaji SK, Priya SB. The effect of fennel seeds on pH of saliva - A clinical study. Indian J Dent Res. 2020 Nov-Dec;31(6):921-923. doi: 10.4103/ijdr.IJDR_185_19.
PubMed 33753665
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cardamom and Fennel on Salivary pH and Anti Microbial Activity
- ClinicalTrials.gov ID
- NCT05245019
- Acronym / sponsor ID
- AIDM
- Conditions
- Electrolyte Disturbance, Saliva Altered
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of KarachiUniversity, hospital or other
- Collaborators
- Altamash Institute of Dental Medicine
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 28 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 17 Feb 2022 (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.
Dental caries is the most prevalent infectious disease related to oral health.. Although significant advances have been made on a global front to prevent caries, studies show its incidence is on the rise making it one of the major chronic diseases affecting all age groups. It possesses not only a great load concerning cost on developed nations but an increasing burden on developing nations. It largely affects children and the lower socioeconomic group hence demanding feasible and inexpensive ways to counter this growing ailment.
Dental caries is a multifactorial disease involving the interaction of the host, agent, and the environment. The primary etiologic agent implicated in dental caries is the streptococcus mutans and non-streptococcus species like Lactobacillus, Actinomyces, and Veillonella species. These oral microbes break down carbohydrates content in the diet, producing acids as by-products. The acids produced lower the pH of plaque and saliva resulting in the demineralization of enamel and dentine, finally enhancing the formation of cavities or dental caries.
The role of saliva in maintaining oral health has been studied extensively over time. The buffering capacity of saliva prevents the teeth from demineralization by maintaining the pH of the oral cavity thereby reducing the risk of dental caries. Since ancient times, medicinal plants and herbs have been used for maintaining oral health. Recent studies have shown fennel seeds and cardamom to play a significant role in regulating the pH of saliva and plaque, and ultimately preventing dental caries.
Cardamom (Elettaria cardamomum) is used as a flavoring agent in foods as well as for treating various cardiovascular, gastrointestinal, and neural problems. In addition, its extracts have shown antimicrobial activity against the principal pathogens causing dental caries and oral candidiasis. The commonest are S. mutans and Lactobacillus.
Fennel (Foeniculum vulgare) is a dry seed used in treating various ailments. Known for its anti-inflammatory, anti-spasmodic, and analgesic properties, it is also widely used for treating gastroenteritis and indigestion. Over time, it has been used in many oral care products for its antiseptic properties and as a breath freshener on its own. Studies have found fennel to not only inhibit the activity of streptococcus Mutans but also cause a significant rise in salivary pH hence depicting the anti-cariogenic activity.
Given the above literature, this study has been designed to record the effects of cardamom and fennel on the salivary pH and their anti-microbial activity on selected microbial species in our population.
Detailed description
This study has been designed to evaluate the effects of cardamom and fennel on oral pH and microbes of the oral cavity.
OBJECTIVES OF THE STUDY:
- To compare the change in pH of the saliva before and after Cardamom use
- To compare the change in pH of the saliva before and after Fennel use
- To compare the pH changes after fennel and cardamom use on patients' saliva
- To evaluate the effects of Cardamom extract on oral pathogens (S. mutans and Lactobacillus)
- To evaluate the effects of Fennel extract on oral pathogens
- To compare the effects of Cardamom and Fennel extract on oral pathogens.
STUDY DESIGN:
Randomized clinical trial
INCLUSION CRITERIA:
- Completely dentate individuals
- Males \& Females Patients ≥ 18 years
- Individuals not undergoing topical fluoride therapy, other chemotherapeutic procedures, antibiotics, and drugs affecting the salivary function or salivary pH
- Individuals not suffering from any systemic diseases/ taking any medication that affects salivary secretion (14).
METHODOLOGY:
Patients coming to the dental setting for a dental checkup or dental procedures, after written informed consent will be enrolled in the study. They will be requested not to take anything orally except plain water for an hour. After an hour they will be required to give salivary samples as control first (control salivary samples). pH will be measured of provided salivary samples with a portable digital pH meter.
Afterward, divided randomly into groups A with a minimum of 25 patients will be given Cardamom (one pod). The second group, Group B will be given Fennel (half teaspoon full, 1.3 grams) to be chewed for 10 minutes under the supervision of the researcher. The saliva will again be collected in clean containers and pH will be assessed.
For the second part of the study, the extract will be prepared with ten grams of fruit powder to be kept in 70% methanol (100ml) for 3 days, followed by filtration and proper storage. Bacteria will be grown from control salivary samples on the required agars. With micro-pathological techniques and expertise, the extract will be applied to the agar and the zone of inhibition will be measured in millimeters on inoculated agar plates with the agar well diffusion method. Standard strains as control will be taken from DDRL Lab. For positive control, Tablet Ciprofloxacin will be used. (12).
Data collected will be evaluated statistically using SPSS 26. For numerical values, mean with standard deviation, and for categorical values percentages will be calculated. To compare before and after paired T-test and to compare between the two treatments, students' T-test will be applied. A value equal to and greater than 0.05 will be considered significant.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Males \& Females Patients ≥ 18 years Individuals not undergoing topical fluoride therapy, other chemotherapeutic procedures, antibiotics, and drugs having an effect upon the salivary function or salivary pH Individuals not suffering from any systemic diseases/ taking any medication that affects salivary secretion
| Arm | Type | Receives |
|---|---|---|
| cardamom group | Experimental | Biological: cardamomthe pH of saliva will be checked first then they r required to chew cardamom nd after 15 minutes again pH will be checked |
| fennel group | Experimental | Biological: fennelthe pH of saliva will be checked first then they r required to chew fennel and after 15 minutes again pH will be checked |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Completely dentate individuals
- Males \& Females Patients ≥ 18 years
- Individuals not undergoing topical fluoride therapy, other chemotherapeutic procedures, antibiotics, and drugs having an effect upon the salivary function or salivary pH
- Individuals not suffering from any systemic diseases/ taking any medication that affects the salivary secretion
Key exclusion criteria (3 listed)
- Patients suffering from systemic diseases
- Patients taking drugs that can effect ph. of saliva
- Patients less then18 years of age -
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 |
|---|---|---|
| cardamomAlso: Elettaria cardamomumcardamom is used as a flavoring agent in foods as well as for treating various cardiovascular, gastrointestinal, and neural problems | Biological | cardamom group |
| fennelAlso: Foeniculum vulgarefennel is Known for its anti-inflammatory, anti-spasmodic, and analgesic properties, it is also widely used for treating gastroenteritis and indigestion. | Biological | fennel group |
Primary outcome
salivary pH
Time frame: 1 Month
Change in pH will be observed before and after cardamom and fennel chewing
1 secondary outcome
anti-microbial activity
Time frame: 1 Month
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 24 May 2022.
- Background: PubMed 33753665Manohar R, Ganesh A, Abbyramy N, Abinaya R, Balaji SK, Priya SB. The effect of fennel seeds on pH of saliva - A clinical study. Indian J Dent Res. 2020 Nov-Dec;31(6):921-923. doi: 10.4103/ijdr.IJDR_185_19.
- 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.
RABIA ARSHAD, Ph.D principal investigator
ALTAMASH INSTITUTE OF DENTAL MEDICINE, KARACHI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cardamom and fennel in people with Electrolyte Disturbance and Saliva Altered, run by University of Karachi 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 4 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: finished, as of the sponsor's last update on 24 May 2022. 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?
salivary pH (time frame: 1 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 NCT05245019, which also lists 1 linked publication.
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 24 May 2022.