| CTRI Number |
CTRI/2022/05/042943 [Registered on: 31/05/2022] Trial Registered Prospectively |
| Last Modified On: |
01/06/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
Modification(s)
|
To see the effect of Madhu Mishrit Panchvalkala Kashaya Kavala and Madhu Mishrit Triphala Kashaya Kavala in specific diseases of oral cavity |
|
Scientific Title of Study
|
Comparative Clinical Evaluation of Madhu Mishrit Panchvalkala Kashaya Kavala and Madhu Mishrit Triphala Kashaya Kavala in Mukhapaka |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Smriti Kaul |
| Designation |
PG Scholar |
| Affiliation |
Patanjali Bhartiya Ayurvigyan evam Anusandhan Sansthan Haridwar |
| Address |
OPD No.3, Patanjali Ayurved Hospital, Patanjali Bhartiya Ayurvigyan evam Anusandhan Sansthan, Haridwar
Patanjali Girls Hostel, Patanjali Bhartiya Ayurvigyan evam Anusandhan Sansthan, Haridwar
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9816584369 |
| Fax |
|
| Email |
smritikaul2675@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Anil Verma |
| Designation |
HOD and Professor |
| Affiliation |
Patanjali Bhartiya Ayurvigyan evam Anusandhan Sansthan |
| Address |
OPD No.3, Patanjali Ayurved Hospital, Patanjali Bhartiya Ayurvigyan evam Anusandhan Sansthan, Haridwar
OPD No.3, Patanjali Ayurved Hospital, Patanjali Bhartiya Ayurvigyan evam Anusandhan Sansthan, Haridwar
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9897298775 |
| Fax |
|
| Email |
dranilverma11@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Anil Verma |
| Designation |
HOD and Professor |
| Affiliation |
Patanjali Bhartiya Ayurvigyan evam Anusandhan Sansthan |
| Address |
OPD No.3, Patanjali Ayurved Hospital, Patanjali Bhartiya Ayurvigyan evam Anusandhan Sansthan, Haridwar
OPD No.3, Patanjali Ayurved Hospital, Patanjali Bhartiya Ayurvigyan evam Anusandhan Sansthan, Haridwar
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9897298775 |
| Fax |
|
| Email |
dranilverma11@gmail.com |
|
|
Source of Monetary or Material Support
|
| Patanjali Bhartiya Ayurvigyan evam Anusandhan Sansthan |
|
|
Primary Sponsor
|
| Name |
Patanjali Ayurved College |
| Address |
Patanjali Ayurved Hospital, Patanjali Bhartiya Ayurvigyan evam Anusandhan Sansthan, Haridwar |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Smriti Kaul |
Patanjali Ayurved Hospital |
OPD No. 3, Department of Shalakya Tantra,Patanjali Ayurved Hospital, Patanjali Bhartiya Ayurvigyan evam Anusandhan Sansthan, Haridwar
Hardwar
UTTARANCHAL |
09816584369
smritikaul2675@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PAC/IEC/2022/19 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:A00-B99||Certain infectious and parasitic diseases. Ayurveda Condition: Specified diseases of oral cavity , (2) ICD-10 Condition:A00-B99||Certain infectious and parasitic diseases. Ayurveda Condition: Diseases of Oral Cavity , |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | kavalaH, कवलः | (Procedure Reference: Sharangdhar samhita 10/4-7, Sushrut Chikitsa 40/62,, Procedure details: Patient will be made to sit comfortably in a room devoid of heavy breeze and sunlight. Patient will be instructed to move the liquid medication in the mouth until watering starts from nose, eyes and mouth and it becomes full of fluid. After the stipulated time (10min.), patient will be instructed to spit out the medication. This procedure will be repeated for 3 times.)
(1) Medicine Name: Triphala Kashaya , Reference: Bhaishajya Ratnavalli,Mukharogachikitsa-87, Bhavprakash Nighantu,Madhya Khand 66/159,160, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 100(ml), Frequency: tds, Duration: 14 Days | | 2 | Intervention Arm | Procedure | - | kavalaH, कवलः | (Procedure Reference: Sharangdhar samhita 10/4-7, Sushrut Chikitsa 40/62, Procedure details: Patient will be made to sit comfortably in a room devoid of heavy breeze and sunlight. Patient will be instructed to move the liquid medication in the mouth until watering starts from nose, eyes and mouth and it becomes full of fluid. After the stipulated time (10min.), patient will be instructed to spit out the medication. This procedure will be repeated for 3 times.))
(1) Medicine Name: Panchvalkala Kashaya , Reference: Bhaishajya Ratnavalli,Mukharogachikitsa-87, Bhavprakash Nighantu,Madhya Khand 66/159,160,, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 100(ml), Frequency: tds, Duration: 14 Days |
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients above 5 years of age.
Patients willing to participate in the trial.
Patients with classical symptoms of Mukhapaka.
Patients yogya for Kavala. |
|
| ExclusionCriteria |
| Details |
Patients below 5 years of age.
Patients not willing for trial.
Patients that are Ayogya for Kavala.
Congenital anomalies of mouth (Cleft lip, Cleft palate, oronasal fistula).
Traumatic wound of mouth (Dentures, sharp edged tooth). |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Routine blood investigations will be carried out for all enrolled patients- CBC, ESR, RBS.
Assessment will be done on the basis of subjective and objective parameters.
|
Before and after treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Assessment will be done on the basis of subjective and objective parameters.
|
Before and after treatment
|
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
02/06/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="6" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In this trial,we are selecting the patients of Mukhapaka in which we will do the intervention in two groups (20 patients in each group). In the group,we will intervene with ayurvedic therapy of Kavala with Madhu Mishrit Panchvalkala Kashaya for 14 days, whereas in other group,we will intervene with ayurvedic therapy of Kavala with Madhu Mishrit Triphala Kashaya for 14 days. Assessment should be done on the basis of Subjective and objective parameters and investigations done during pre - treatment and post treatment as discussed earlier. |