An open labeled randomised comparative controlled clinical study to evaluate the efficacy of patoladi gel in the management of mukhapaka with special reference to stomatitis
Trial Snapshot
- Phase
- Phase 2/3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- To cure mukhapaka (stomatitis)(mouth ulcers)
Study Overview
Brief Summary
In Nidana Sthana, Sushruta has first time described the Mukharogas(diseases affecting the oral cavity) and he has classified the diseases of Mukha, Mukha is a complex structure formed by the combination of Ostha (Lips), Dantamoola(Gums), Danta (Teeth), Jihva (Tongue), Taalu (Palate), Gala (Throat), and Sarvasara (All over Mukha).
Stomatitis can be included in one group of the Mukha Rogas, known as “Sarvasara Rogas†The aim of any medical science is for the attainment of level of health which enables every individual to lead a happy life socially and economically.
In this regard Ayurveda stands first as it is the science which primarily aims at preservation of positive health and correction of ill health. Oral hygiene plays an important role in every individual. But due to so many vitiating factors like tobacco chewing, smoking, stress, vitamin deficiency, allergic and trauma leading to the Vatadi Dosha and produce 67 Mukha Rogas.
The Drugs choosen here have both Shamana and Ropana property, and the drugs which are used for this preparation are economic and commonly available and within the reach of common people
In this study the form of drug is changed to “GEL†form which is very convenient to use and palatable
It may give fast and good results.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 40.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Patients from the age group of 18 – 40 years.
- •2.Patients having all classical symptoms of Mukhapaka.
- •3.Male patients having hemoglobin more or equal to 13gm/dl whereas Female patients having hemoglobin more or equal to 11gm/dl.
Exclusion Criteria
- •1.Patients having hyperplasia or neoplasia of buccal cavity 2.Ulcer due to Diabetes, Herpes, Tuberculosis and patients with addiction to tobacco etc.
- •3.Patient of known case of uncontrolled Hypertension, Diabetes , Thyroid.
- •4.Immunocompromised patients.
Outcomes
Primary Outcomes
To cure mukhapaka (stomatitis)(mouth ulcers)
Time Frame: 8th Day,15th Day
Secondary Outcomes
- To cure stomatitis(8th Day, 15th Day)
Investigators
Dr Manjiri Keskar
Parul Institude of Ayurved