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Comparative Study Of Poly Herbal Gel In Treatment Of mouth Ulcers

Comparitive Evaluation Of Polyherbal Mucoadhesive Gel Formulation In Treatment Of Oral Apthous Ulcers - A Randomised, Double Blind Controlled Clinical Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/08/009201
Enrollment
310
Registered
2017-08-01
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Oral Ulcers

Interventions

Intervention1: polyherbal formulation: Group 1 will receive polyherbal formulation gel contains Glycyrrhiza glabra extract, Acacia catechu extract, Punica granatum extract, Curcuma longa extract and

Sponsors

Self sponsered
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Healthy men or women with no systemic disease aged between 18 to 60 years. 2. Having mouth ulcer of size >2 mm at easily accessible location in the mouth allowing easy evaluation and treatment. 3. Having mouth ulcers associated with pain. 4. Patients who agree not to use any other medication to treat mouth ulcer during the study period. 5. Patients willing to comply with the study schedule and procedures and willing to come for regular follow-up visits. 6. Patients or legally acceptable representative (LAR) of patient willing to sign and date the written informed consent to participate in the study.

Exclusion criteria

Exclusion criteria: 1. Presence of any systemic disease. 2. History of drug or alcohol abuse. 3. Taking systemic or topical corticosteroids. 4. Pregnant women or lactating mothers. 5. History of HIV or other viral infections. 6. History of any antibiotic therapy in past 3 months. 7. History of oral prophylaxis within 6 months previous to the study. 8. Patients with mouth breathing habit. 9. Patients using orthodontic and prosthodontics appliances 10. Patients who are on analgesics or antiseptics. 11. Patients who have received any periodontal therapy in the past 6 months. 12. History and evidence of any type of carcinoma

Design outcomes

Primary

MeasureTime frame
Ulcer size reduction. Reduction in number of ulcers. Number of ulcers healed. Pain reduction by assessing pain intensity on VAS scale Timepoint: 0,1,3,5,7

Secondary

MeasureTime frame
Reports of any adverse or serious adverse events. Any abnormal vital signs or lab parameters. Duration of ulcer (days needed to achieve complete healing) Number and frequency of application. Timepoint: 1,3,5,7 DAYS

Countries

India

Contacts

Public ContactRIMJHIM SAHU

PCMS & RC BHOPAL

vijaythawani@rediffmail.com9826310177

Outcome results

None listed

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