Skip to content

Ayurvedic treatment of chronic mouth ulcer

Comparative clinical evaluation of Ayurvedic regimen in the management of oral submucous fibrosis: A prospective pilot study

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/07/043816
Enrollment
30
Registered
2022-07-07
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-01

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

Conditions

Health Condition 1: K135- Oral submucous fibrosis

Interventions

Intervention1: Ayurvedic regimen for Group-I:: 1. Saptachhadadi Kashaya: Kavala (Gurgling) 15 ml twice daily 2. Irimedadi Taila: Local application with the help of cotton swab/ dropper- 5 ml twice da

Sponsors

CCRAS
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients aged between 18 years-60 years with OSMF are diagnosed clinically. 2. Patients who have not taken any treatment earlier for OSMF. 3. Patients who are ready to quit the habit of betel quid/ areca nut/ gutkha chewing and are willing for regular follow-ups.

Exclusion criteria

Exclusion criteria: 1. Extensive fibrosis with severe trismus with an inter incisal distance (IID) 2. Pregnant and lactating mothers. 3. Disease is most advanced with premalignant and malignant changes 4. Generalized fibromatosis 5. Oral manifestation of scleroderma 6. Oral lichen planus 7. Pale oral mucosa of anemia mimicking blanching 8. Chronic debilitating conditions such as DM, HT, HIV, etc. 9. Patients not willing to give up addiction habits of Gutka, Panâ??Masala, tobacco, etc.

Design outcomes

Primary

MeasureTime frame
a.Relief/ changes in the clinical manifestation of OSMF (stomatitis, palpable fibrotic band, tongue protrusion and inter-incisal distance) Timepoint: Duration of treatment: Medication for 84 days (12 weeks) Follow up: 04 weeks without medication Total study Duration: 6 months

Secondary

MeasureTime frame
a. Changes in the real-time ultrasonography with high-frequency transducers, electromyography, and histopathological findings. b. Changes in the Quality of life of the patient Timepoint: baseline, and at the end of 84th day

Countries

India

Contacts

Public ContactDr Kshirod Kumar Ratha

Central Ayurveda Research Institute, CCRAS, Bharatpur, Bhubaneswar. Khordha ORISSA 751029 India

drkkratha@gmail.com06742387702

Outcome results

None listed

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