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Clinical Trials/CTRI/2020/02/023395
CTRI/2020/02/023395
Recruiting
Phase 2

ââ?¬Å?Clinical And Histopathological Evaluation Of Ayurvedic Formulation In The Management Of Oral Submucous Fibrosis.ââ?¬?

Ministry of AYUSH0 sites0 target enrollmentTBD
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ConditionsHealth Condition 1: D10- Benign neoplasm of mouth and pharynx

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Health Condition 1: D10- Benign neoplasm of mouth and pharynx
Sponsor
Ministry of AYUSH
Status
Recruiting
Last Updated
3 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
3 years ago
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\. Volunteers with diagnosed cases of oral sub mucous fibrosis clinically.
  • •2\. Systemically healthy volunteers will be included.
  • •3\. Patients willing to give written informed consent to participate in the study for 3 months excluding 2 weeks without drug for follow\-up.

Exclusion Criteria

  • •1\. Persons not willing to participate in the study.
  • •2\. Smokers, tobacco and/ or pan masala chewers, not ready to quit the habit.
  • •3\. Persons having clinical evidence of malignant change, extension of the disease either onto the pharynx or floor of mouth.
  • •4\. Pregnant and lactating women.
  • •5\. Persons having systemic diseases or conditions, which can be worsened by the use of steroids.
  • •6\. Persons already undergoing some OSMF treatment.
  • •7\. H/o hypersensitivity to any of the control or the trial drug or any of its ingredients.
  • •8\. Patients who have completed participation in any other clinical trial during the past six (06\) months.
  • •9\. Any other condition which the Investigator thinks may jeopardize the study.

Outcomes

Primary Outcomes

Not specified

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