Efficacy of Unani Formulations (HBR and SBM) for Treating Uncomplicated UTIs

NCT06742918 | Completed DMC

• 1 other identifier: Hamdard University, Pakistan
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief 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. The objective of the study is as follows.

1. 1.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.
2. 2.The prices of allopathic medicines are increasing day by day so the investigator wants to give a cost-effective alternative solution.
3. 3.To explore alternative treatments for Urinary Tract Infections with no or less antimicrobial resistance.

Conditions

Urinary Tract Infections; Alternative Medicine; Women Health

Outcome Measures

Primary Outcomes (3)

• 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).

  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.

  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.

  14-days

Secondary Outcomes (2)

• 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

Study Arms (4)

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

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.

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

Other: Placebo

Placebo

PLACEBO COMPARATOR

Group IV received placebo.

Other: Placebo

Interventions

Placebo OTHER

Placebo was given to the Group IV which was 2 grams of glucose.

Group III was given the combination of Tablet HBR and Syrup SBM.; Placebo; Syrup SBM; Tablet HBR is Aqueous extract of Berberis.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Gender Eligibility Details: Females having symptoms with UTI
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hamdard University: lead

Study Sites (1)

Shifa-ul-Mulk Memorial Hospital

Karachi, Sindh, Pakistan

Location

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Tabiba Huma Sayeed Siddiqui, M.Phil

  Hamdard University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: 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.

Study Record Dates

• First Submitted: May 14, 2024
• First Posted: December 19, 2024
• Study Start: March 17, 2021
• Primary Completion: September 11, 2021
• Study Completion: December 14, 2021
• Last Updated: December 19, 2024

Record last verified: 2024-12

Locations

PA (1)