| CTRI Number |
CTRI/2021/04/033154 [Registered on: 27/04/2021] Trial Registered Prospectively |
| Last Modified On: |
16/04/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study the Efficacy Between Haritaki Kashaya Kawal And Darvyadi Kashaya Kawal In The Management Of Chronic Pharyngitis. |
|
Scientific Title of Study
|
A Randomized Controlled Clinical Trial To Compare The Efficacy Between Haritaki Kashaya Kawal And Darvyadi Kashaya Kawal In The Management Of Chronic Pharyngitis. |
| Trial Acronym |
HKDKCP |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bhagyashree Bajirao Godase |
| Designation |
PG 1st Year |
| Affiliation |
PDEAs College of Ayurveda And Research Centre Akurdi Pune |
| Address |
Ayurved Rugnalaya & Sterling Multispeciality Hospital, Sector No 27, Nigdi Pradhikaran, Pune
PDEAS College of Ayurved and Research Center, Sector No 25, Nigdi Pradhikaran, Pimpri Chinchwad, Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
8208530718 |
| Fax |
|
| Email |
bgfriends.net@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chandana Virkar |
| Designation |
Professor And HOD of Shalakyatantra |
| Affiliation |
PDEAs College of Ayurveda And Research Centre Akurdi Pune |
| Address |
Ayurved Rugnalaya & Sterling Multispeciality Hospital, Sector No 27, Nigdi Pradhikaran, Pune
PDEAS College of Ayurved and Research Center, Sector No 25, Nigdi Pradhikaran, Pimpri Chinchwad, Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
9822199107 |
| Fax |
|
| Email |
drvirkarchandana@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chandana Virkar |
| Designation |
Professor And HOD of Shalakyatantra |
| Affiliation |
PDEAs College of Ayurveda And Research Centre Akurdi Pune |
| Address |
Ayurved Rugnalaya & Sterling Multispeciality Hospital, Sector No 27, Nigdi Pradhikaran, Pune
PDEAS College of Ayurved and Research Center, Sector No 25, Nigdi Pradhikaran, Pimpri Chinchwad, Pune
MAHARASHTRA
411044
India |
| Phone |
9822199107 |
| Fax |
|
| Email |
drvirkarchandana@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAs College of Ayurveda And Research Centre Akurdi Pune |
|
|
Primary Sponsor
|
| Name |
PDEAs College of Ayurveda And Research Centre |
| Address |
Sector No 25, Nigdi Pradhikaran, Pimpri Chinchwad, Pune - 411044 |
| Type of Sponsor |
Private medical college |
|
|
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 Bhagyashree Bajirao Godase |
Ayurved Rugnalaya And Sterling Multi Speciality Hospital, Nigdi |
OPD No 122, Department - Shalakyatantra (ENT), Sector No 27, Nigdi Pradhikaran, Pune – 411044
Pune
MAHARASHTRA |
8208530718
bgfriends.net@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J312||Chronic pharyngitis. Ayurveda Condition: CHRONIC PHARYNGITIS, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Darvyadi Kashaya Kawal |
Group B 28 patients will be treated with Darvyadi Kashaya Kawal for 7days. Dose will be as per requirement. Route of administration will be oral route and the frequency will be twice in a day for total 7 days. Duration of Therapy- Follow up for each patient will be on 3rd, 7th and 15th day. |
| Intervention |
Haritaki Kashaya Kawal |
Group A 28 patients will be treated with Haritaki Kashaya Kawal for 7 days. Dose will be as per requirement. Route of administration will be oral route and the frequency will be twice in a day for total 7 days. Duration of Therapy- Follow up for each patient will be on 3rd, 7th and 15th day. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
i. Patients of age between 18 to 60 years.
ii. Patients who complains symptoms of Chronic Pharyngitis.(Throat pain (Galashool)
Swelling in throat (Gala shotha)
Tiredness of Voice (Swarbheda)
Congestion of posterior pharyngeal wall and pillars (Aaraktata)
Dysphagia (gilankashatta)
Cough (kasa)
iii. Patients who are willing to give consent for this study.
|
|
| ExclusionCriteria |
| Details |
i. Known cases of Chronic productive cough, Chronic Sinusitis, Tonsillitis.
ii. Known cases of Bronchiolitis, Pneumonia.
iii. Not willing to give consent.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the efficacy between Haritaki Kashaya Kawal and
Darvyadi Kashaya Kawal in the management of Chronic
Pharyngitis. |
Follow up on 3rd, 7th and 15th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
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
|
N/A |
|
Date of First Enrollment (India)
|
03/05/2021 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Chronic
Pharyngitis is a chronic inflammatory condition of the pharynx.It
pathologically is characterized by hypertrophy of mucosa, seromucinous glands,
subepithelial lymphoid follicles and even the muscular coat of the pharynx. It
is of two types:
1. Chronic
catarrhal pharyngitis
2. Chronic
hypertrophic (granular) pharyngitis
It is one of
the upper respiratory tract diseases which troubles the person by hindering the
day today activities due to broad spectrum of etiology, it quite from allergens
to infections The long-term use of antibiotics in patients with recurrent sore
throat has harmful effect on their health so for this Shamana therapy is
introduced in Ayurveda which includes oral administration of medicine is of
utmost importance as the administration is very easy and effective compared to Shodhana
or any Panchakarma. 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 Kawal Chikitsawhich provides good
relief in Mukhagat and Gala rogas.Present study will be carried out to see the
scientific rational of Haritaki Kashaya Kawal dharan and Darvyadi Kashaya Kawal
dharan in Chronic Pharyngitis. Hence the study titled as,“A Randomized
Controlled Clinical Trial to Compare the Efficacy between Haritaki Kashaya
Kawal and Darvyadi Kashaya Kawal in the management of Chronic Pharyngitis .†has
been planned |