| CTRI Number |
CTRI/2024/07/071139 [Registered on: 23/07/2024] Trial Registered Prospectively |
| Last Modified On: |
23/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Role of Kataphaladi Kashaya kavala and Darvyadi Kashaya kavala in the management of Galagrah w.s.r. to Pharyngitis |
|
Scientific Title of Study
|
A COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF KATAPHALADI KASHAYA KAVALA AND DARVYADI KASHAYA KAVALA IN THE MANAGEMENT OF GALAGRAH with special reference TO PHARYNGITIS |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NA |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Uma Kirar |
| Designation |
Pg Scholar |
| Affiliation |
Mansarovar ayurvedic medical hospital and reseach center Bhopal madhya pradesh |
| Address |
Fourth floor room no.4 Department Of Shalakya tantra Mansarovar ayurvedic medical college hospital and research center Bhopal madhya pradesh
Bhopal
MADHYA PRADESH
462042
India |
| Phone |
9753015573 |
| Fax |
|
| Email |
ukscience2017@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shubhangi Lohokare |
| Designation |
Associate Professor |
| Affiliation |
Mansarovar ayurvedic medical hospital and reseach center Bhopal madhya pradesh |
| Address |
Fourth floor room no.4 Department Of Shalakya tantra Mansarovar ayurvedic medical hospital and research center Bhopal madhya pradesh
Bhopal
MADHYA PRADESH
462042
India |
| Phone |
9890698452 |
| Fax |
|
| Email |
shindeshubh84@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shubhangi Lohokare |
| Designation |
Associate Professor |
| Affiliation |
Mansarovar ayurvedic medical hospital and reseach center Bhopal madhya pradesh |
| Address |
Fourth floor room no.4 Department Of Shalakya tantra Mansarovar ayurvedic medical hospital and research center Bhopal madhya pradesh
MADHYA PRADESH
462042
India |
| Phone |
9890698452 |
| Fax |
|
| Email |
shindeshubh84@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mansarovar ayurvedic Medical college hospital and research centre, Hinotiya Alam, Kolar Road, Bhopal - 462042, India |
|
|
Primary Sponsor
|
| Name |
Mansarovar Ayurvedic Medical College hopital and research center |
| Address |
Fourth floor room no.4 Department Of Shalakya tantra Mansarovar ayurvedic medical hospital and research center Bhopal madhya pradesh 462042 |
| 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 |
| Dr Uma Kirar |
Mansarovar ayurvedic medical college hospital and research center Bhopal madhya pradesh |
Fourth floor room no 4 Department Of Shalakya tantra Mansarovar ayurvedic medical college hospital and research centre Bhopal 462042
Bhopal
MADHYA PRADESH |
09753015573
ukscience2017@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional Ethics Committee Mansarovar Ayurvedic Medical College hospital and research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J028||Acute pharyngitis due to other specified organisms. Ayurveda Condition: GALAGRAHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | kavalaH, कवलः | (Procedure Reference: Sharangdhar Shamita madhyamkhanda, Procedure details: Kavala with kataphaladi kashaya two times a day for 7 days )
(1) Medicine Name: Kataphaladi kashaya , Reference: Sharangdhar Shamita Madhyamkhanda , Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 200(ml), Frequency: bd, Duration: 7 Days | | 2 | Comparator Arm | Procedure | - | KAVALA | (Procedure Reference: Sharangdhar Shamita Madhyamkhanda , Procedure details: Kavala with Darvyadi Kashaya two times a day for 7days )
(1) Medicine Name: Darvyadhi Kashaya , Reference: ï¶sharangdhar Shamita Madhyamkhanda, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 200(ml), Frequency: bd, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient suffering from symptoms of Galagrah (Gala shool, Gala Shotha, Swarbheda, Jwar etc.) mentioned in ayurveda classical text.
Patients Yogya for kavala.
|
|
| ExclusionCriteria |
| Details |
Patient suffering from any growth, tumour or malignancy of pharynx.
Patient who needs surgical intervention.
Patient of Galagrah who is under other treated modalities.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the kataphaladhi Kashaya kavala and Darvyadhi kashaya Kavala in the the management of Galagrah w.s.r. to pharyngitis |
2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the kataphaladhi Kashaya kavala and Darvyadhi kashaya Kavala in the the management of Galagrah w.s.r. to pharyngitis |
2 weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
16/08/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Pharyngitis (Galagraha) is a very common problem in routine practice in all age group. It is one of the upper respiratory tract diseases which troubles the person by hindering the day today activities due to identical nidana, lakshana and upashaya. The long duration of treatment by antibiotic in the chronic pharyngitis and not specific surgical role, discourages the patient and doctors. Patient often feel himself ill, out of the proportion of the disease. This disease mainly occurs due to vitiation of kapha dosha which settles in Mukha (Gala) Pradesh causing shotha (inflammation) of Gala Pradesh. Katphalati Kashaya Kavala and Darvyadi Kashaya Kavala drug formulation has been selected to study the efficacy in the management Chronic Pharyngitis (galagraha). It is having kaphghana karma& extreme usage in mukha ,galarogas. Overall, while there may be some variation in the prevalence rate depending on the specific population and region being studied, adult pharyngitis is a significant health concern in India and should be evaluated by a healthcare professional if symptoms persist. The long-term use of antibiotics in patients with recurrent sore throat has lot of harmful effect on their health. Hence there is need of hour to get a best remedy to overcome this problem. Many herbal combinations are described in Ayurveda by various Acharyas with their therapeutic effect in Chronic Pharyngitis is yet to be explored. Acharya Vagbhat has mentioned the Kavala Chikitsa which provides good relief in Mukhagat and Gala rogas. Present study was carried out to see the scientific rational of Katphalati Kashaya Kavala dharan and Darvyadi Kashaya Kavala dharan in Pharyngitis. |