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Effect of two Panchavalkala formulations in UTI

Comparison of efficacy of two classical Ay. references of Panchavalkala in resistant E. coli strains (A pre-clinical & exploratory clinical study in UTI)

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/06/043533
Enrollment
44
Registered
2022-06-28
Start date
Unknown
Completion date
Unknown
Last updated
2022-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N390- Urinary tract infection, site notspecified

Interventions

None listed

Sponsors

All India Institute of Ayurveda
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients of grade 2 UTI where E.coli is found resistant to ampicillin 2. Patients voluntarily willing to participate in the study 3. Patients having no allergic history to medicines prescribed 4. Patients having atleast two of the following signs/symptoms: a) chills with rigors or warmth associated with fever b) flank or pelvic pain c) Dysuria, urinary frequency, or urgency d) Costovertebral angle tenderness or physical examination 5) Dipstick analysis positive for leukocyte esterase or atleast 10 WBC/mm3

Exclusion criteria

Exclusion criteria: 1) During the pregnancy and lactation period 2) Patients with high-grade fever ( >104) and allergic to Penicillin 3) Renal transplantation 4) Suspected or confirmed prostatitis 5) Receipt pf effective antibacterial drug in less than 24 hrs 6) History of trauma to pelvis or urinary tract 7) Patients not willing

Design outcomes

Primary

MeasureTime frame
1) resistant E.coli strain observed as sensitive 2) Clinical or microbiological response: a) resolution of symptoms present at entry point and no new symptoms b) bacterial pathogens 1000 CFU/ml on urine culture than on entry point 3) Clinical / microbiological response: a) No resolution or addition of new symptoms b) bacteria in urine culture remains same or increased than urine culture at entry pointTimepoint: zero seven fourteen and twenty one days

Secondary

MeasureTime frame
1) 20% improvement in laboratory markers (CBC, ESR, Urine Routine Microscopy & Culture Sensitivity) 2) 20% improvement in clinical conditions of associated disease 3) Improvement in Quality of Life (QOL-BREF scores)Timepoint: zero seven fourteen and twenty one days

Countries

India

Contacts

Public ContactGeetika Pahuja

All India Institute of Ayurveda

gtkpahuja@gmail.com8750737430

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026