CTRI/2023/11/060382 [Registered on: 30/11/2023] Trial Registered Prospectively
Last Modified On:
21/11/2024
Post Graduate Thesis
Yes
Type of Trial
Interventional
Type of Study
Ayurveda
Study Design
Randomized, Parallel Group Trial
Public Title of Study
To assess effectiveness of Panchapallava Kashaya and Arka into Mukhapaka
Scientific Title of Study
Formulation modification of Panchapallava Kashaya into Arka and Evaluate their Antimicrobial Activity (in vitro) and Clinical Efficacy in Pittaja Mukhapaka (Recurrent Aphthous Stomatitis)
Trial Acronym
Nil
Secondary IDs if Any
Secondary ID
Identifier
NIL
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Naghera Ankita Ramsi bhai
Designation
PG Scholar
Affiliation
Government Ayurved College , Vadodara
Address
Upgraded department of Rasashastra and Bhaishajya Kalpana Government Ayurved College, Ajwa road, Dhanvantari marg, Panigate Vadodara GUJARAT 390019 India Upgraded department of Rasashastra and Bhaishajya Kalpana Government Ayurved College, Ajwa road, Dhanvantari marg, Panigate Vadodara GUJARAT 390019 India Vadodara GUJARAT 390019 India
Phone
9327406368
Fax
Email
ankitanaghera21@gmail.com
Details of Contact Person Scientific Query
Name
Dr Bharti Umretia
Designation
MD (Ayu)
Affiliation
Government Ayurved College , Vadodara
Address
Upgraded department of Rasashastra and Bhaishajya Kalpana Government Ayurved College, Ajwa road, Dhanvantari marg, Panigate Vadodara GUJARAT 390019 India Upgraded department of Rasashastra and Bhaishajya Kalpana Government Ayurved College, Ajwa road, Dhanvantari marg, Panigate Vadodara GUJARAT 390019 India Vadodara GUJARAT 390019 India
Phone
7600011944
Fax
Email
dr.bhartiumrethia@gmail.com
Details of Contact Person Public Query
Name
Dr. Kruti Vyas
Designation
MD (Ayu), Ph.D
Affiliation
Government Ayurved College , Vadodara
Address
Upgraded department of Rasashastra and Bhaishajya Kalpana Government Ayurved College, Ajwa road, Dhanvantari marg, Panigate Vadodara GUJARAT 390019 India Upgraded department of Rasashastra and Bhaishajya Kalpana Government Ayurved College, Ajwa road, Dhanvantari marg, Panigate Vadodara GUJARAT 390019 India Vadodara GUJARAT 390019 India
Phone
9426393726
Fax
Email
vyas_krt@yahoo.com
Source of Monetary or Material Support
Government Ayurved College and Hospital, Ajwa road, Dhanvatari marg, Panigate, Vadodara- 390019
Primary Sponsor
Name
Government Ayurved Hospital Vadodara
Address
Government Ayurved Hospital, Ajwa road, Dhanvantari marg, Panigate Vadodara
Type of Sponsor
Research institution and hospital
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
India
Sites of Study
No of Sites = 1
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Naghera Ankita
Government Ayurveda Hospital, Vadodara
Opd no 22 Government Ayurveda Hospital, Vadodara, Gujarat Vadodara GUJARAT
(Procedure Reference: Chakradatta Mukharoga Chikitsa -32, Procedure details: Kavala is a procedure of holding small quantity of liquid in the mouth; make it move briskly inside and spitting out quickly.
2 times per day for 7 days) (1) Medicine Name: Panchapallava Kashaya, Reference: Chakradatta Mukharoga Chikitsa -32, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 100(ml), Frequency: bd, Duration: 7 Days
2
Intervention Arm
Procedure
-
kavalaH, कवलः
(Procedure Reference: Arkapraksha Shatak 1/46, Procedure details: Kavala is a procedure of holding small quantity of liquid in the mouth; make it move briskly inside and spitting out quickly.
2 times per day for 7 days) (1) Medicine Name: Panchapallava Arka, Reference: Arkaprakasha Shatak 1/46, Route: Oral, Dosage Form: Arka, Dose: 100(ml), Frequency: bd, Duration: 7 Days
Inclusion Criteria
Age From
18.00 Year(s)
Age To
60.00 Year(s)
Gender
Both
Details
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.
ExclusionCriteria
Details
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.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
On-site computer system
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
Dahayukta Vrana (ulcer with burning sensation )
Rakta Pitta Sphotayukta ( Red & yellow vesicle )
Ksharokshitsama Vrana (Resemble like alkali burn )
30 days
Secondary Outcome
Outcome
TimePoints
improve oral hygiene
30 days
Target Sample Size
Total Sample Size="30" Sample Size from India="30" Final Enrollment numbers achieved (Total)= "32" Final Enrollment numbers achieved (India)="32"
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 randomized
clinical 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). All
patients 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, like
Number 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 Vrana
symptoms. 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.
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.