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Testing an Indian Gooseberry Spray for Dry Mouth in People with Diabetes

Effect of Phyllanthus emblica oral spray in the treatment of hyposalivation in patients with Diabetes Mellitus - a case controlled double blinded randomized clinical trial - NIL

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/06/089866
Enrollment
60
Registered
2025-06-30
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

Health Condition 1: E119- Type 2 diabetes mellitus without complications

Interventions

None listed

Sponsors

Blessy Judesly S
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Type 2 Diabetic patients (level of HbA1c greater than 6 percentage) with unstimulated whole salivary flow rate less than 0.3ml per min and stimulated whole salivary flow rate less than 1.5ml per min, Xerostomia CTCAE grading mild and moderate will be included, Patients who are willing to participate in the intervention study

Exclusion criteria

Exclusion criteria: Patients who are under age of 30 years, Patients with other systemic disorders and on long term corticosteroids, Patients with type 1 diabetes mellitus, Patients who are under radiation therapy and chemotherapy, Pregnancy and lactation, Patients who have other mucosal lesions, Patients with psychiatric disorder, Patient with salivary gland disease, Patients with habit of smoking and alcohol, Patients not willing to participate in the study.

Design outcomes

Primary

MeasureTime frame
Change in salivary flow rate, salivary protein, pH and taste perception before and after intervention.Timepoint: salivary analysis every week for 4 weeks

Secondary

MeasureTime frame
nilTimepoint: nil

Countries

India

Contacts

Public ContactDr Blessy Judesly

SRM Dental College Ramapuram Chennai

krithika.sekar@gmail.com9444333977

Outcome results

None listed

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