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Clinical Trials/CTRI/2020/12/029467
CTRI/2020/12/029467Not yet recruitingPhase 2/3

A COMPARATIVE CLINICAL STUDY TO EVALUATE EFFICACY OF YASHTIMADHU SIDHHA PAYAH KAVALA WITH BABUL TWAK KWATH KAVALA IN PITTAJ MUKHAPAKA.

Principal PDEAs College Of Ayurved And Research Centre1 site in 1 country60 target enrollmentStarted: January 12, 2020Last updated:

Trial Snapshot

Phase
Phase 2/3
Status
Not yet recruiting
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
To evaluate efficacy of yashtimadhu sidhha payah kavala(lukewarm) for gargle and rince the mouth to its full capacity and babul twak kwath kavala (lukewarm) for gargle and rince the mouth to its full capacity, once a day for 10 days in pittaj mukhapaka.

Study Overview

Brief Summary

mukhapaka is pitta nanatmaja and rakta pradoshaj vyadhi. it is characterised by vedanayukta vrana commonly. in ancient text books cause of disease is given as poor oral hygeinic conditions , mixed food habbituals, rakta pradoshak aahar and vihar. Due to changed life style all these reason we can see in daily routine of most of the people , like pooor oral hygeinic conditions due to no tooth brush use , use of mishri, habbits like aireted drinks , smoking cigarettes, tobacco chewing , also we can see change in day today time table of maximum people like awaking in night, sleeping in day time after meal, no exercise, food made with mchemicals, work in excessive heat or cold, increased use of air conditioners, mainly mixed type of food eating , acidic food which eventually leads to aggrevation of causitive factors for mukhapaka. Mukhapaka like signs and symptoms are sen in recurrent mouth ulcer or stomatitis. as per study from nov 2020 to dec 2012 , 21.7% patients were suffering from recurrent apthous ulcer having mukhapaka like sign and symptoms.

In ayurveda ancient text books given all information about mukhapaka disease. caused , sign symptoms, prevention care and treatmenet , etc. India is tropical country having harsh hot, humid climate. as per(ncbi.nim.nih) incidence rate is of 20%, which is quit high. most of people  neglect causes and disease to which leads to major complication . so it’s need of now a days to find easiest, affordable and ancient technique of treatment  for majority of people. Ayurvedic text having many medicined kalpana’s are given , among those kavala . pratisaran , alepan are apllied mostly to mukhapaka. In this kavala kalpana , as perAshtang sangraha adhyay 26/178 , treatment of madhurgan sidhha payah kavala is given. it is applied here. In madhurgan yashtimadhu is one drug which is used in vrana chikitsa and it is included in madhurgana also, also seeing its availability it is easily available. So, to prevent further complication and treat disease in easiest simple , affordable way yashtimadhusidhhapayah kavala is selected. compairing yashtimadhu sidhha payah kavala with babul twak kwath kaval will give its efficacy.

Study Design

Study Type
Interventional
Allocation
Coin toss, Lottery, toss of dice, shuffling cards etc
Masking
Open Label

Eligibility Criteria

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

Inclusion Criteria

  • 1.Patients having classical sign and symptoms of mukhapaka, like asyavrana, asyaruja, asyadaha, asyavairasyata, jivhasfutan, salivation, difficulty in diglutition.
  • age between 18-60years.
  • recurrent oral ulcer with symptoms of mukhapaka.

Exclusion Criteria

  • Agantuja Mukhapaka(like traumatic etc.)
  • Patients recently undergone oral surgeries (history of surgery done in last 1 year).
  • Infective stomatitis.
  • Allergic stomatitis.
  • Mukhapaka associated with systemic disease eg.
  • Haematological disease, gastrointestinaltrack diseases , bahcet’s disease, HIV, diabetic ulcer, etc.
  • Major aphthous ulcer, herpatic from ulcer.
  • Dermatological disease like vesiculloballous disease.
  • Neoplastic squamous cell carcinoma, other malignant carcinoma.

Outcomes

Primary Outcomes

To evaluate efficacy of yashtimadhu sidhha payah kavala(lukewarm) for gargle and rince the mouth to its full capacity and babul twak kwath kavala (lukewarm) for gargle and rince the mouth to its full capacity, once a day for 10 days in pittaj mukhapaka.

Time Frame: 10 days with follow up on 5th and 10th day.

Secondary Outcomes

  • 1. to compare and study the efficacy of yashtimadhu sidhha payah kavala.(2. to compare and study the efficacy of babul twak kwath kavala in pittaj mukhapaka.)

Investigators

Sponsor
Principal PDEAs College Of Ayurved And Research Centre
Sponsor Class
Private medical college

Study Sites (1)

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