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Exploring Kakamachi (Solanum nigrum) Extract as a Natural and Safe Pupil Dilator Compared to Standard Eye Drops

A clinical study to evaluate the efficacy and safety of Kakamachi (Solanum nigrum ) extract as a natural pupil dilator in comparison with conventional pharmaceutical agent- tropicacyl plus - NIL

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/04/085126
Enrollment
40
Registered
2025-04-21
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-28

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

Conditions

Health Condition 1: H578- Other specified disorders of eye and adnexa

Interventions

None listed

Sponsors

Dr. Karthika A
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Participants requiring ophthalmoscopic examination 2. Participants of both genders 3. Age above 18 years to 80 years

Exclusion criteria

Exclusion criteria: 1. Severe systemic diseases (uncontrolled diabetes, hypertension, cardiovascular diseases), severe neurological disorders (stroke, cognitive impairment), or active infections 2. Advanced ocular pathologies (retinal detachment, macular degeneration, advanced diabetic retinopathy, ocular tumors, cataracts, corneal conditions, uveitis, endophthalmitis) 3. Recent ocular surgeries or trauma (cataract surgery, LASIK, retinal surgery, globe rupture, hyphema) 4. Use of medications affecting ocular health (systemic steroids, antivirals, ocular steroids) or other contraindicated drugs 5. Severe ocular media opacities (vitreous, lens) 6. Anatomical issues affecting imaging (small or unusually shaped eyes) 7. Ocular tumors (intraocular melanoma, retinoblastoma) 8. Severe glaucomatous damage (high intraocular pressure, optic nerve damage) 9. Corneal conditions (severe scarring, dystrophies, infections)

Design outcomes

Primary

MeasureTime frame
To assess the effectiveness of Kakamachi extract in inducing pupil dilation compared to standard synthetic dilators.Timepoint: Assessment will be done using an ophthalmoscope at baseline before administration and at 15, 30, 45, and 60 minutes post administration

Secondary

MeasureTime frame
To evaluate the duration and size of pupil dilation before and after the application of Kakamachi extract or Tropicacyl plus using Auto-refractometer.Timepoint: Measurement of pupil size using auto-refractometer at baseline before administration and at 15, 30, 45, and 60 minutes post administration

Countries

India

Contacts

Public ContactDr Khemchandra L Mahajan

Parul Institute of Ayurved and Research

khemchandra.mahajan86270@paruluniversity.ac.in9834461296

Outcome results

None listed

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