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A clinical endpoint study to assess the effect of dental cream, strontium chloride 10% w/w medicated dental cream on blood glucose levels in healthy male subjects.

A prospective, open label, single centre, single arm, clinical endpoint study to evaluate the effect of strontium chloride 10% w/w medicated dental cream on blood glucose levels in healthy adult human male subjects under fasting conditions.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/05/068009
Enrollment
52
Registered
2024-05-28
Start date
Unknown
Completion date
Unknown
Last updated
2024-10-14

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

Conditions

None listed

Interventions

Intervention1: SENSOFORM® (Strontium Chloride 10% w/w Medicated Dental Cream): 1.5 ± 0.2gm of tooth paste for 2min brushing as external application but not for consumption. Total duration of the inter

Sponsors

Indoco Remedies Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Healthy human male subjects within the age range of 18 to 55 years (inclusive of both) 2. Body-mass index of more than or equal to 18.5 kg/m2 and less than or equal to 30.0 kg/m2, with body weight not less than 50 kg. 3. Willingness to provide written informed consent to participate in the study. 4. Absence of significant disease, laboratory examinations within acceptable range, medical history and with normal physical examination during the screening. 5. Comprehension of the nature and purpose of the study and compliance with the requirement of the protocol.

Exclusion criteria

Exclusion criteria: 1. Personal / family history or presence of allergy or hypersensitivity to Strontium Chloride or to any of the components of the formulations. 2. History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder. 3. Presence of tooth sensitivity 4. Difficulty in brushing due to tooth decay 5. History of donation of blood (one unit) within 3 months prior to study check-in or difficulty in donating blood. 6. Participation in a drug research study within past 3 months

Design outcomes

Primary

MeasureTime frame
Changes in blood glucose levelsTimepoint: Baseline (0.00) to 15, 30 and 60 minutes post application of toothpaste—

Secondary

MeasureTime frame
Changes in salivary pHTimepoint: Baseline (0.00) to 15, 30, 60, 120 and 180 minutes post application of toothpaste.;To examine the subject’s acceptance by assessing palatability questionnaireTimepoint: Within 15 minutes of post brushing—

Countries

India

Contacts

Public ContactMr Chirag Khatri

AnaCipher Clinical Research Organisation

srikanth.n@anacipher.com9133278073

Outcome results

None listed

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