Urinary Tract InfectionsHBR-SBMNCT06742918
Efficacy of Unani Formulations (HBR and SBM) for Treating Uncomplicated UTIs
A study of Urinary Tract Infections and Alternative Medicine, run by Hamdard University at 1 site in Pakistan.
Trial summary
Based on a huge literature search a gap is found for a complete cure of Urinary Tract Infection (UTI) through the management of traditional antibiotic medicine. Therefore, there is a need to develop a cost-effective, easily available, and more potent drug for the management of UTI. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Urinary Tract Infections, Alternative Medicine, Women Health
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 sitePakistan
- Study dates
- 17 Mar 2021to 14 Dec 2021
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women between the ages of 18 to 70 years have symptoms of UTI.
- Women living in Karachi and the surrounding goth (villages) of Hamdard University came into the study settings.
- Women with pregnancy, Type II Diabetes mellitus, and recurrent UTI.
- Women with every socioeconomic status.
- Females either married or unmarried.
- Women having menopause
Who cannot join
- Women having chronic renal and liver disease.
- Women who have recently used antibiotics.
- Women with complicated UTIs.
- Women having a menstrual cycle during the checkup.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: To Evaluate the Effect of Berberis Extract (HBR) for the Management of Urinary Tract Infections in Females Measured the Efficacy of HBR, and SBM and Their Combination on Uropathogens to Resolve the Manifestations of UTI in Females
Based on a huge literature search a gap is found for a complete cure of Urinary Tract Infection (UTI) through the management of traditional antibiotic medicine. Therefore, there is a need to develop a cost-effective, easily available, and more potent drug for the management of UTI.
The objective of the study is as follows.
Read more
- UTI in women is a neglected area in underdeveloped countries due to behavioral factors and zero death ratio in women therefore conduct a clinical study of the Unani formulation to assess the efficacy of the formulation.
- The prices of allopathic medicines are increasing day by day so the investigator wants to give a cost-effective alternative solution.
- To explore alternative treatments for Urinary Tract Infections with no or less antimicrobial resistance.
It is a comparative study comparing two formulations in three groups. Participants of Group-I received tablet HBR (HBR group), group-II was given syrup SBM (SBM group) and group-III was given a combination of tablets and syrup (HBR+SBM group) daily twice on an empty stomach for 14 days.
Participants visited the clinic after taking medicine for one week and then the second week.
On the first visit and day 14, patients had their checkups and tests. Hence, the justification for this study is to identify the antimicrobial activity of locally available plant materials and their formulations i.e. HBR and SBM, which have been used in Unani medicine practice for a long. Moreover, conduct a clinical trial for the determination of efficacy and drug resistance of these formulations.
Read the detailed description
Urinary Tract Infection is one of the most common infections globally, and worldwide about 81% of women are involved with UTI. This occurs most frequently between the ages of 16 to 35 years. About 27% of women with a first episode of UTI record a recurrent within 6 months and 48% within the first year. In uncomplicated UTI, the microorganisms involved are Uropathogenic E.coli, Klebsiella pneumoniae, Staphylococcus saprophyticus, Group B Streptococcus, Pseudomonas aeruginosa, and Staphylococcus aureus in Urinary culture. UTI needs proper diagnosis and prompt management, as if left untreated it can have serious consequences with a chance of progression to chronic disease. Therefore there is a need for an alternative solution for its management especially in developing areas.
The current study was designed as randomized clinical trials of a minimum of 76 female patients, conducted in multi-centers for 14 days, as the disease manifested in acute conditions. The Human Trials were conducted from March 2021 to December 2021. Unani Formulations HBR and SBM were used to treat Uncomplicated Urinary Tract Infections.
Tablet HBR was made as an Aqueous Extract of Berberis roots. the species used here was Berberis aristata. HBR (Aqueous extract of Berberis) is black, having a bitter taste and a pungent smell. It gives Yellowish black/ golden color when dissolved in water.
The ingredients of SBM are as follows:
Cichorium intybus seeds Cichorium intybus Roots Cucumis sativus L Seed Cucumis melo L. Seed Foeniculum vulgare Mill seeds Foeniculum vulgare Mill roots Tribulus terrestris Linn. fruits The Tablets and syrup were made by standard methods described in the literature.
Every registered patient filled out a Case Report Form (CRF) and Temperamental assessment form, each participant then went through the screening for UTI i.e. taking Vitals, Ultrasound KUB (Kidney, Urinary bladder), Blood tests (CBC, Serum Urea, and Serum Creatinine), Urinary Physical Examination, Urine Detail Report (DR) and Urine Culture as baseline investigations.
Patients were randomized to receive test drugs for one week either HBR 1 tablet BD on an empty stomach or syrup SBM 1 tablespoon twice a day on an empty stomach or a combination of both. All females were advised to follow up after one week. After a verbal assessment of the symptoms, another week of medicines was given to the participants. After two weeks of medicines, each participant was tested again for Urine Detailed Report and Urine Culture.
The data was analyzed and assessed by Statistical Package for Social Sciences (SPSS) version 22. It was expressed as the mean ± Standard Deviation (SD), frequency of age groups, ethnic groups, signs and symptoms, temperament, and micro-organisms before and after treatment was assessed. Cross tabulations, Chi-Square was applied for comparison of the variants. Cross-tabulation Pearson's Chi-Square Test analyzed drug compliance. The side effects were observed. A comparison of the cost of the conventional antibiotics and test drugs was done.
- Conditions
- Urinary Tract Infections, Alternative Medicine, Women Health
- Being tested
- Placebo
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
Placebo was given to the Group IV which was 2 grams of glucose.
| Study group | Role | What they receive |
|---|---|---|
| Syrup SBM | Active comparator | A Unani formulation which was used since many year to resolve the urinary symptoms, and is described in Unani and Ayurveda Books. This group was designed to observe its antimicrobial effects on Uropathogens Receives: Other: Placebo |
| Tablet HBR is Aqueous extract of Berberis. | Experimental | Group II was given Tablet HBR (Aqueous extract Berberis). In a literature search it was found that Berberis was very effective against Uropathogens, especially E.coli. Receives: Other: Placebo |
| Group III was given the combination of Tablet HBR and Syrup SBM. | Experimental | The study was designed to identify the efficacy of the combination of the two medicines i.e. Tablet HBR and Syrup SBM, as HBR is a good antimicrobial aqueous extract and Syrup SBM is a very efficacious diuretic medicine. therefore, the combined effects were observed Receives: Other: Placebo |
| Placebo | Placebo comparator | Group IV received placebo. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Unani formulations HBR & SBM show significant antibacterial effects against E.coli in UTIs, offering a promising alternative to antibiotics.
The Unani formulation, comprising Tablet HBR (aqueous extract of Berberis) and Syrup SBM, has demonstrated antimicrobial and diuretic properties, particularly against E. coli, the most prevalent uropathogens.
Literature suggests that HBR exhibits significant antimicrobial activity, while Syrup SBM possesses diuretic properties. This synergistic effect can potentially eliminate microbes from the urinary tract. In light of the growing concern of antimicrobial resistance (AMR) associated with synthetic Allopathic antibiotics, this study aims to investigate the efficacy of Tablet HBR and Syrup SBM as alternative antimicrobial and diuretic agents for uncomplicated urinary tract infections (UTIs).
Measured: 14-days
In clinical response, the combination of HBR & SBM showed an improvement or resolution of signs and symptoms, e.g. resolution of burning micturition, lower abdominal pain, smell in urine, etc.
In the two follow-ups, only the side effect observations found was excessive urination in some patients, otherwise, there was no side effect observed. there was complete improvement or resolution in signs and symptoms observed during and after 14 days of the trials.
Measured: 14-days
The combination of Unani Formulations was estimated Cost effective for the trial period of 14-days in outpatients.
The current market value in the local market of one course of fourth generation Antibiotic costs is very high. The cost of Tablet HBR for one course is nominal, and the combination of both Unani Formulations for one course of treatment also costs low. The high annual costs of conventional UTI medicines are another indicator of the burden they place on society. It was estimated that the Unani formulations would not burden society.
Measured: 14-days
Secondary outcomes (2)
The combination of HBR & SBM showed no side effects observed in the 14-day trial.
After 14 days of acute trial, it was found that there were no major side effects from either the Unani formulations, Tablet HBR, or Syrup SBM. The only minor side effect showed was excessive diuresis in some patients.
Measured: 14-days
Improvement in Blood pressure measurements in some patients.
The combination of HBR \& SBM showed a lowering effect on blood pressure in some patients. SBM is a diuretic medicine and due to this effect, Blood pressure is lowered, especially in the summer season.
Measured: 14-days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2024
- Study start17 Mar 2021
- Primary completion11 Sep 2021
- Study completion14 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionsStudies 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
- Model description
- Group I was given the Tablet HBR (Aqueous extract Berberis), Group II received Syrup SBM (A Unani Formulation), and Group III was given a combination of both. The groups were divided based on the treatment findings to evaluate the efficacy of the medicines, i.e. whether these medicines are effective individually against Uropathogens of in combination.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamdard University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tabiba Huma Sayeed, Hamdard University
- Investigators
- Tabiba Huma Sayeed Siddiqui, M.Phil, Principal investigator, Hamdard University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06742918
- Sponsor's protocol ID
- Hamdard University, Pakistan
- Acronym
- HBR-SBM
- Status last verified
- Dec 2024
- First submitted
- 14 May 2024
- Last updated
- 19 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Effect of Berberis Extract (HBR) for the Management of Urinary Tract Infections in Females Measured the Efficacy of HBR, and SBM and Their Combination on Uropathogens to Resolve the Manifestations of UTI in Females
- ClinicalTrials.gov ID
- NCT06742918
- Acronym / sponsor ID
- HBR-SBM / Hamdard University, Pakistan
- Conditions
- Urinary Tract Infections, Alternative Medicine, Women Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Hamdard UniversityUniversity, hospital or other
- Study start
- 17 Mar 2021 (actual)
- Primary completion
- 11 Sep 2021 (actual)
- Study completion
- 14 Dec 2021 (actual)
- First posted
- 19 Dec 2024 (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.
Based on a huge literature search a gap is found for a complete cure of Urinary Tract Infection (UTI) through the management of traditional antibiotic medicine. Therefore, there is a need to develop a cost-effective, easily available, and more potent drug for the management of UTI.
The objective of the study is as follows.
- UTI in women is a neglected area in underdeveloped countries due to behavioral factors and zero death ratio in women therefore conduct a clinical study of the Unani formulation to assess the efficacy of the formulation.
- The prices of allopathic medicines are increasing day by day so the investigator wants to give a cost-effective alternative solution.
- To explore alternative treatments for Urinary Tract Infections with no or less antimicrobial resistance.
It is a comparative study comparing two formulations in three groups. Participants of Group-I received tablet HBR (HBR group), group-II was given syrup SBM (SBM group) and group-III was given a combination of tablets and syrup (HBR+SBM group) daily twice on an empty stomach for 14 days.
Participants visited the clinic after taking medicine for one week and then the second week.
On the first visit and day 14, patients had their checkups and tests. Hence, the justification for this study is to identify the antimicrobial activity of locally available plant materials and their formulations i.e. HBR and SBM, which have been used in Unani medicine practice for a long. Moreover, conduct a clinical trial for the determination of efficacy and drug resistance of these formulations.
Detailed description
Urinary Tract Infection is one of the most common infections globally, and worldwide about 81% of women are involved with UTI. This occurs most frequently between the ages of 16 to 35 years. About 27% of women with a first episode of UTI record a recurrent within 6 months and 48% within the first year. In uncomplicated UTI, the microorganisms involved are Uropathogenic E.coli, Klebsiella pneumoniae, Staphylococcus saprophyticus, Group B Streptococcus, Pseudomonas aeruginosa, and Staphylococcus aureus in Urinary culture. UTI needs proper diagnosis and prompt management, as if left untreated it can have serious consequences with a chance of progression to chronic disease. Therefore there is a need for an alternative solution for its management especially in developing areas.
The current study was designed as randomized clinical trials of a minimum of 76 female patients, conducted in multi-centers for 14 days, as the disease manifested in acute conditions. The Human Trials were conducted from March 2021 to December 2021. Unani Formulations HBR and SBM were used to treat Uncomplicated Urinary Tract Infections.
Tablet HBR was made as an Aqueous Extract of Berberis roots. the species used here was Berberis aristata. HBR (Aqueous extract of Berberis) is black, having a bitter taste and a pungent smell. It gives Yellowish black/ golden color when dissolved in water.
The ingredients of SBM are as follows:
Cichorium intybus seeds Cichorium intybus Roots Cucumis sativus L Seed Cucumis melo L. Seed Foeniculum vulgare Mill seeds Foeniculum vulgare Mill roots Tribulus terrestris Linn. fruits The Tablets and syrup were made by standard methods described in the literature.
Every registered patient filled out a Case Report Form (CRF) and Temperamental assessment form, each participant then went through the screening for UTI i.e. taking Vitals, Ultrasound KUB (Kidney, Urinary bladder), Blood tests (CBC, Serum Urea, and Serum Creatinine), Urinary Physical Examination, Urine Detail Report (DR) and Urine Culture as baseline investigations.
Patients were randomized to receive test drugs for one week either HBR 1 tablet BD on an empty stomach or syrup SBM 1 tablespoon twice a day on an empty stomach or a combination of both. All females were advised to follow up after one week. After a verbal assessment of the symptoms, another week of medicines was given to the participants. After two weeks of medicines, each participant was tested again for Urine Detailed Report and Urine Culture.
The data was analyzed and assessed by Statistical Package for Social Sciences (SPSS) version 22. It was expressed as the mean ± Standard Deviation (SD), frequency of age groups, ethnic groups, signs and symptoms, temperament, and micro-organisms before and after treatment was assessed. Cross tabulations, Chi-Square was applied for comparison of the variants. Cross-tabulation Pearson's Chi-Square Test analyzed drug compliance. The side effects were observed. A comparison of the cost of the conventional antibiotics and test drugs was done.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- Group I was given the Tablet HBR (Aqueous extract Berberis), Group II received Syrup SBM (A Unani Formulation), and Group III was given a combination of both. The groups were divided based on the treatment findings to evaluate the efficacy of the medicines, i.e. whether these medicines are effective individually against Uropathogens of in combination.
| Arm | Type | Receives |
|---|---|---|
| Syrup SBM | Active comparator | Other: PlaceboA Unani formulation which was used since many year to resolve the urinary symptoms, and is described in Unani and Ayurveda Books. This group was designed to observe its antimicrobial effects on Uropathogens |
| Tablet HBR is Aqueous extract of Berberis. | Experimental | Other: PlaceboGroup II was given Tablet HBR (Aqueous extract Berberis). In a literature search it was found that Berberis was very effective against Uropathogens, especially E.coli. |
| Group III was given the combination of Tablet HBR and Syrup SBM. | Experimental | Other: PlaceboThe study was designed to identify the efficacy of the combination of the two medicines i.e. Tablet HBR and Syrup SBM, as HBR is a good antimicrobial aqueous extract and Syrup SBM is a very efficacious diuretic medicine. therefore, the combined effects were observed |
| Placebo | Placebo comparator | Other: PlaceboGroup IV received placebo. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Women between the ages of 18 to 70 years have symptoms of UTI.
- Women living in Karachi and the surrounding goth (villages) of Hamdard University came into the study settings.
- Women with pregnancy, Type II Diabetes mellitus, and recurrent UTI.
- Women with every socioeconomic status.
- Females either married or unmarried.
Key exclusion criteria (4 listed)
- Women having chronic renal and liver disease.
- Women who have recently used antibiotics.
- Women with complicated UTIs.
- Women having a menstrual cycle during the checkup.
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 |
|---|---|---|
| PlaceboPlacebo was given to the Group IV which was 2 grams of glucose. | Other | Group III was given the combination of Tablet HBR and Syrup SBM., Placebo, Syrup SBM, Tablet HBR is Aqueous extract of Berberis. |
Primary outcome
The Unani formulations HBR & SBM show significant antibacterial effects against E.coli in UTIs, offering a promising alternative to antibiotics.
Time frame: 14-days
The Unani formulation, comprising Tablet HBR (aqueous extract of Berberis) and Syrup SBM, has demonstrated antimicrobial and diuretic properties, particularly against E. coli, the most prevalent uropathogens. Literature suggests that HBR exhibits significant antimicrobial activity, while Syrup SBM possesses diuretic properties. This synergistic effect can potentially eliminate microbes from the urinary tract. In light of the growing concern of antimicrobial resistance (AMR) associated with synthetic Allopathic antibiotics, this study aims to investigate the efficacy of Tablet HBR and Syrup SBM as alternative antimicrobial and diuretic agents for uncomplicated urinary tract infections (UTIs).
In clinical response, the combination of HBR & SBM showed an improvement or resolution of signs and symptoms, e.g. resolution of burning micturition, lower abdominal pain, smell in urine, etc.
Time frame: 14-days
In the two follow-ups, only the side effect observations found was excessive urination in some patients, otherwise, there was no side effect observed. there was complete improvement or resolution in signs and symptoms observed during and after 14 days of the trials.
The combination of Unani Formulations was estimated Cost effective for the trial period of 14-days in outpatients.
Time frame: 14-days
The current market value in the local market of one course of fourth generation Antibiotic costs is very high. The cost of Tablet HBR for one course is nominal, and the combination of both Unani Formulations for one course of treatment also costs low. The high annual costs of conventional UTI medicines are another indicator of the burden they place on society. It was estimated that the Unani formulations would not burden society.
2 secondary outcomes
The combination of HBR & SBM showed no side effects observed in the 14-day trial.
Time frame: 14-days
Improvement in Blood pressure measurements in some patients.
Time frame: 14-days
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 19 Dec 2024.
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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.
Tabiba Huma Sayeed Siddiqui, M.Phil principal investigator
Hamdard University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Urinary Tract Infections and Alternative Medicine, run by Hamdard University 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 6 inclusion and 4 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 19 Dec 2024. 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. 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?
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?
The Unani formulations HBR & SBM show significant antibacterial effects against E.coli in UTIs, offering a promising alternative to antibiotics. (time frame: 14-days). 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 19 Dec 2024.