To assess effectiveness of Panchapallava Kashaya and Arka into Mukhapaka
- Conditions
- Recurrent oral aphthae. Ayurveda Condition: MUKHAROGAH,
- Registration Number
- CTRI/2023/11/060382
- Lead Sponsor
- Government Ayurved Hospital Vadodara
- Brief Summary
The clinical study was carried out after permission from institutional ethics committee clearance (GAV/VAD/IEC/82/2023, Dated 13/03/2023) and retrospectively registered at Clinical Trial Registry of India, ICMR, New Delhi, vide CTRI/2023/11/060382 [Registered on 30/11/2023]. The study type was an interventional, open label parallel arm randomizedclinical trial. In Group A, Panchapallava Kashaya and in Group B, Panchapallava Arka with dose schedule for Kavala Q.S. (100 ml) twice a day in morning and evening was given for 7 days with 1 month follow up. 55 patients were screened and 32 patients were enrolled for clinical trial. 32 patients were randomly divided into two groups (16 in both group). Allpatients completed the trial. It explores with the description of the aims and objectives,materials and methods, criteria of selection of the patients, general observations, and effect of therapy. Also, a detailed description about the diagnostic criteria for Pittaja Mukhapaka (Recurrent Aphthous Stomatitis) along with the subjective criteria, like Dahayukta Vrana, Ksharokshitasama Vrana, Tiktavaktrata, Rakta Pitta Sphotayukta and objective criteria, likeNumber of ulcers, Site of ulcers, Margin of ulcers, Size of ulcer, Pain and Tenderness for the assessment of results were stated here. Specialized scoring patterns for criteria for assessment was adopted and assessed in terms of percentage relief, The effect of the trial drug on signs and symptoms of disease before and after treatment and statistical evaluation. Thereafter the observations and results are presented in tabular form followed by interpretation. After completion of treatment, the efficacy of the therapy was assessed on the basis of the improvement in the subjective criteria and objective with scoring patterns.
Maximum numbers of patients (68.75 %) were from the age group of 18-30 years, females(59.37 %), unmarried (59.37 %) and Hindu (93.75 %) by religion. Maximum number of patients (40.62 %) were graduate, students (56.25 %), upper middle class (68.75 %), urban are (93.75 %). Maximum 75 % of patients were having gradual onset, 81.25 % were having onset in childhood, 68.75 % were having progressive nature. All the patients were having Dahayukta Vrana and Ksharokshitasama Vranasymptoms. 18.75 % of patients had Tiktavaktrata and 9.37 % Rakta Pitta Sphotayukta. 90.62% of patients showed 1-2 number of ulcers, Maximum 46.87 % of patients showed site of were inside lips, 78.12 % of patients had red margin, 40.62 % of patients had 2-4 mm size of ulcers, 59.37 % of patients experienced mild, annoying pain, 81.25 % of patients had the ability to eat liquid due to ulceration. Associated conditions like stress were found in (37.50 %) of patients, Past history of Recurrent Aphthous Stomatitis was present in all patients.93.75 % of patients didn’t have any family history.
Maximum numbers of patients (93.75 %) were having inclination towards Katu Rasa, Ushana Ahara, , 78.12 % patients had Vishmagni, 87.50 % of patients were vegetarian, 65.62 % patients were habitual to Samashana, 84.37 % of patients had Madhyama Kshudha, 56.25 % of patients had Madhyama Koshtha, 81.25 % of patients had sound sleep, 59.37 % of patients were addicted to tea, 68.75 % of patients were mental occupations, 40.62 % of patients had regular Artava Pravruti, bowel habits were regular in 75 % of patients, 96.87 % of patients had solid stool consistency.
Maximum patients were having Pitta-Kapha Prakriti (53.12 %), Rajasika ManasaPrakriti (100 %), Madhyama Sara (100 %), Madhyama Samhanana (96.87 %), MadhyamaPramana (84.37 %), Madhyama Satmya (71.87 %), Madhyama Satva (90.62 %), Madhyama Abhyavarana Shakti (84.37 %), Madhyama Jarana Shakti (84.37 %), Madhyama Vaya(100%), Avara Vyayama Shakti (75 %).
All patients were having regular Nadi. 90.61 % of patients exhibited Nirama and Pitta Mala Pravruti, 62.5 % had Nirama Jihva, 96.87 % Avishesha Shabda, 93.75 % Samashitoshna Sparsha, 100 % had Prakrita Drika, 84.37 % Madhyama Akriti
In subjective criteria, relief was found in Dahayukta Vrana in Group A (84.38 %) and Group B (92.31 %), Rakta Pitta Sphotayukta symptoms in Group A (100 %) and unchanged in Group B (0 %). Tiktavakrata symptoms has relieved (80 %) in compare Group B (100 %) and Ksharokshitasama Vrana symptom in was decreased Group A (77.27 %) and Group B (92 %).
In objective criteria, relief was found in number of ulcers in both Group A (76.47 %) and Group B (88.89 %), red margin of ulcers in Group A (90.91 %) and Group B (90.91 %), erythematous margin of ulcers in Group A (50 %) and Group B (66.67 %), pain in Group A (91.67 %) and Group B (94.44 %) and tenderness in Group A (94.59 %) and in Group B (91.30 %). No adverse drug reaction was found in any patients.
Both Groups found highly significant results in symptoms of Dahayukta Vrana and Ksharokshitasama Vrana, while non-significant in Rakta Pitta Sphotayukta and Tiktavakrata.Both groups found highly significant results in objective criteria; number of ulcers, site of ulcers, size of ulcers, pain and tenderness, while non-significant in erythematous margin of ulcers. In red margin of ulcers found highly significant result in Group B, while significant results in Group A.
In a comparison between Group A and Group B, data revealed no statistically significant difference was found in the subjective criteria and in the objective criteria.
In overall effect of Panchapallava Kashaya in (Group A) Pittaja Mukhapaka, 68.75 % of the patients showed complete remission, 18.75 % of the patients showed mild improvement, 6.25 % showed marked improvement, 6.25 % showed unchanged and 0 % showed moderate improvement. In overall effect of Panchapallava Arka (Group B) in Pittaja Mukhapaka, 81.25 % of the patients showed complete remission, 12.5 % of the patients showed unchanged and 6.25 % showed marked improvement and No patients were found in moderate and mild improvement in disease.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 30
- Patients having classical sign and symptoms of Pittaja Mukhapaka.
- Ulcer present on any site of mouth like tongue, buccal mucosa, inside the lips, palates.
- Ulcer 1-5 in numbers Size is less than 10 mm.
- Tend to recurrence at less than 2 months interval.
- Age : Below 18 years and above 60 years.
- Traumatic : Thermal, Radiation, Eosinophilic ulcer.
- Major aphthous ulcer, herpetic form ulcer.
- Associated with systemic diseases : HIV infection, Syphilitic ulcer, Diabetic ulcer.
- Associated with dermatological disease.
- Neoplastic : Squamous cell carcinoma, others malignant neoplasm.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Dahayukta Vrana (ulcer with burning sensation ) 30 days Rakta Pitta Sphotayukta ( Red & yellow vesicle ) 30 days Ksharokshitsama Vrana (Resemble like alkali burn ) 30 days
- Secondary Outcome Measures
Name Time Method improve oral hygiene 30 days
Trial Locations
- Locations (1)
Government Ayurveda Hospital, Vadodara
🇮🇳Vadodara, GUJARAT, India
Government Ayurveda Hospital, Vadodara🇮🇳Vadodara, GUJARAT, IndiaNaghera AnkitaPrincipal investigator9327406368ankitanaghera21@gmail.com