| CTRI Number |
CTRI/2025/05/086805 [Registered on: 13/05/2025] Trial Registered Prospectively |
| Last Modified On: |
09/05/2025 |
| 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 evaluate an add-on effect of
katphaladi churna with darwyadi kwath kavala in the management of acute
pharyngitis |
|
Scientific Title of Study
|
A randomized comparative clinical trial to evaluate an add-on effect of
katphaladi churna with darwyadi kwath kavala in the management of acute
pharyngitis |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aniket Dhembare |
| Designation |
PG Scholar |
| Affiliation |
PDEAS College of Ayurved and Research Centre ,nigdi ,Pune |
| Address |
PDEAS College Of Ayurved And Research Center Third Floor Shalakyatantra Dept sec 25 Pradhikaran Nigdi pune
Pune
MAHARASHTRA
Pune
MAHARASHTRA
411044
India |
| Phone |
9011128884 |
| Fax |
|
| Email |
aniketpatil1112@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrSandeepDarunde |
| Designation |
Asso professor |
| Affiliation |
PDEAS College of Ayurved and Research Centre ,nigdi ,Pune |
| Address |
PDEAS College of Ayurved And Research Center 3rd floor Shalakya Dept sector 25 pradhikaran Nigdi pune
Pune
MAHARASHTRA
Pune
MAHARASHTRA
411044
India |
| Phone |
8983088238 |
| Fax |
|
| Email |
sdw420@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aniket Dhembare |
| Designation |
PG Scholar |
| Affiliation |
PDEAS College of Ayurved and Research Centre ,nigdi ,Pune |
| Address |
PDEAS College Of Ayurved And Research Center Third Floor Shalakya Dept sec 25 Pradhikaran Nidhi pune
Pune
MAHARASHTRA
Pune
MAHARASHTRA
411044
India |
| Phone |
9011128884 |
| Fax |
|
| Email |
aniketpatil1112@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAS College of ayurved and research centre sector 25 nigdi pradhikaran Pune maharashtra 411044 |
|
|
Primary Sponsor
|
| Name |
PDEAS college of Ayurved And Research centre Nigdi pune |
| Address |
PDEAS College of ayurved and research centre 3rd floor shalakyatantra department sector 25 nigdi pradhikaran Pune maharashtra |
| 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 Aniket Dhembare |
Ayurved Rugnalaya and sterling multi-speciality hospital |
Shalakyatantra dept 125 ground floor
Pune
MAHARASHTRA |
9011128884
aniketpatil1112@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Chairperson Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J02||Acute pharyngitis. Ayurveda Condition: GALAGRAHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: KATPHALADI CHOORNA7,8,9,10, Reference: शारंगधर संहिता मध्यम खंड 6/39-40, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: Honey), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Darvyadi kwatha kavala, Reference: अष्टांगहृदय उत्तरस्थटन २२/५४, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients presenting any 2 of the signs & symptoms i.e.
a. Pain while swallowing/difficulty in swallowing
b. Fever
c. Enlarged tonsills
d. Dysphagia
e. Lymphadenopathy.
f. Redness of pharynx.
2. Patients between the Age Group 18 to 50 years irrespective of gender. |
|
| ExclusionCriteria |
| Details |
1. Patients having other complications such as acute retropharyngeal abscess,
pharyngeal abscess, otitis media.
2. Patient who need surgical intervention.
3. Pregnant & lactating woman.
4. Patients suffering from malignancy, heart diseases, asthma. |
|
|
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 evaluate the add-on effect of Katphaladi choorna with Darvyadi kwatha Kavala on
throat pain wihin 7 days Acute pharyngitis |
To evaluate the add-on effect of Katphaladi choorna with Darvyadi kwatha Kavala on
throat pain wihin 7 days Acute pharyngitis |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
evaluate the add on effect of Katphaladi choorna with Darvyadi kwatha Kavala on
other than symptoms of within 7 days Acute pharyngitis |
7 days |
|
|
Target Sample Size
|
Total Sample Size="31"
Sample Size from India="31"
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)
|
12/06/2025 |
| 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
|
Acute Pharyngitis is Infection & Inflammation of the Pharyngeal mucosa & submucosa, which affects the back portion of Throat. Acute sore throat, primarily referring to acute pharyngitis, is a common reason for patients of all ages to consult ENT physicians. Modern medical treatment typically involves the administration of antibiotics, which can alleviate symptoms but may also cause many side effects. Increasing resistance is also a problem faced today due to irrational use of antibiotics.Ayurveda has long utilized medicines derived from plants, animals, and minerals to treat diseases. The disease mainly occurs due to vitiation of Kapha Dosha which settles in Gala Pradesh causing shotha (inflammation) of Gala Pradesh. |