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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- The Unani formulations HBR & SBM show significant antibacterial effects against E.coli in UTIs, offering a promising alternative to antibiotics.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
It is a randomized clinical trial. Participants are the patients who came randomly into the settings and enrolled based on inclusion and exclusion criteria. They are divided into three groups. Group I received Tablet HBR (Aqueous Extract Berberis), Group II received Syrup SBM (a Unani formulation) and Group III received a combination of both.
Investigator is the researcher of the study.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
The Unani formulations HBR & SBM show significant antibacterial effects against E.coli in UTIs, offering a promising alternative to antibiotics.
时间窗: 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.
时间窗: 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.
时间窗: 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.
次要结局
- The combination of HBR & SBM showed no side effects observed in the 14-day trial.(14-days)
- Improvement in Blood pressure measurements in some patients.(14-days)
研究者
Tabiba Huma Sayeed
Lecturer
Hamdard University