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Clinical Trials/CTRI/2016/06/006987
CTRI/2016/06/006987RecruitingPhase 2

Further Study On Ayurvedic Management Of Sarvasara wsr To Oral Submucous Fibrosis(OSMF)

IPGT AND RA1 site in 1 country30 target enrollmentStarted: April 3, 2016Last updated:
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Trial Snapshot

Phase
Phase 2
Status
Recruiting
Sponsor
Enrollment
30
Locations
1
Primary Endpoint
Increase in interincisal distance
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

Oral Submucous Fibrosis (OSMF) is a chronic debilitating disease of the

oral cavity resulting from habits like smoking, alcoholism, mawa,

pan-masala, gutkha, tobacco, betel nut and betel quid chewing.

In Group A First of all Erandbhristha Haritaki will be given for

Kosthasuddhi for 3 days followed by Shadabindu Taila Shodhan Nasya for

5 days. After that following treatment will be given simultaneously for 45

days.

· Madhu-pippalyadi Yoga for Pratisarana.

· Nishadi Taila for Kavala.

RasayanaYoga orally

In Group B Physiotherapy and antioxidants M V NERVE OD

Study Design

Study Type
Interventional
Allocation
Other
Masking
Open Label

Eligibility Criteria

Ages
18.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •The patients having clinical signs and symptoms of OSMF-blanching and stiffness of oral mucosa, trismus, burning sensation in mouth, intolerance to eating hot and spicy foods, repeated vesicular eruption and ulceration on the bucal mucosa, palate, and pillars; reduced mobility of soft palate and tongue, loss of gustatory sensation etc.
  • •Interincisal distance between 15mm-40mm.

Exclusion Criteria

  • •Extensive fibrosis of all the oral mucosa, severe trismus with an interincisal distance of less than 15mm.
  • •Disease is most advanced with premalignant and malignant changes.
  • •Generalized fibromatosis.
  • •Oral manifestation of scleroderma.
  • •Oral lichen planus.
  • •Pale oral mucosa of anemia.
  • •Chronic debilitating conditions like DM, HT, HIV etc.
  • •Patients not willing to give up habits of gutkha, pan-masala, mawa, tobacco, betel quid or betel nut chewing.

Outcomes

Primary Outcomes

Increase in interincisal distance

Time Frame: 45 days

Secondary Outcomes

  • Relief from symptoms of oral submucous fibrosis(45 days)

Investigators

Sponsor
IPGT AND RA
Sponsor Class
Research institution and hospital

Study Sites (1)

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