| CTRI Number |
CTRI/2024/07/070938 [Registered on: 22/07/2024] Trial Registered Prospectively |
| Last Modified On: |
19/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparative study of efficacy of Sariva decoction gargling with Triphala decoction gargling in the management of pharyngitis |
|
Scientific Title of Study
|
A Randomised controlled clinical trial to compare the efficacy of Sariva Kwatha Kawala with Triphala Kwatha
Kawala in the management of Galagraha. |
| 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 Pragati Nikam |
| Designation |
MS Scholar Shalakyatantra |
| Affiliation |
Tilak Ayurveda Mahavidyalaya |
| Address |
Tilak Ayurveda Mahavidyalaya Department of Shalakyatantra 2nd
floor 583/2 Rasta Peth Pune.
Pune
MAHARASHTRA
411011
India |
| Phone |
9324058467 |
| Fax |
|
| Email |
pragatinikam4@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prakash Guddimath |
| Designation |
Associate Professor Shalakyatantra Department |
| Affiliation |
Tilak Ayurveda Mahavidyalaya |
| Address |
Tilak Ayurveda Mahavidyalaya Department of Shalakyatantra 2nd
floor 583/2 Rasta Peth Pune.
Pune
MAHARASHTRA
411011
India |
| Phone |
9527545122 |
| Fax |
|
| Email |
drprakashig@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pragati Nikam |
| Designation |
MS Scholar Shalakyatantra |
| Affiliation |
Tilak Ayurveda Mahavidyalaya |
| Address |
Tilak Ayurveda Mahavidyalaya Department of Shalakyatantra 2nd
floor 583/2 Rasta Peth Pune.
Pune
MAHARASHTRA
411011
India |
| Phone |
9324058467 |
| Fax |
|
| Email |
pragatinikam4@gmail.com |
|
|
Source of Monetary or Material Support
|
| Seth Tarachand Ramnath Charitable Ayurvedic Hospital, 580/2 Rasta Peth, Pune, 411011, Maharashtra, India.
|
|
|
Primary Sponsor
|
| Name |
Tilak Ayurveda Mahavidyalaya |
| Address |
Tilak Ayurveda Mahavidyalaya Department of Shalakyatantra 2nd
floor 583/2 Rasta Peth Pune 411011 |
| 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 Pragati Nikam |
Seth Tarachand Ramnath Ayurvedic Hospital Pune |
Tilak Ayurveda
Mahavidyalaya
Department of
Shalakyatantra
Ophthalmology OPD 14
1st floor 583/2 Rasta
Peth Pune
Pune
MAHARASHTRA |
9324058467
pragatinikam4@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional ethical committe, TAMV pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:B95-B97||Bacterial and viral infectious agents. Ayurveda Condition: GALAGRAHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | kavalaH, कवलः | (Procedure Reference: ashtang hriday sutrasthan 22/12, Procedure details: Taking sufficient amount of medicated fluid in mouth such that the fluid can be moved in
mouth is called as kawala)
(1) Medicine Name: sariva, Reference: charak sutrasthan 4/9, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 60(ml), Frequency: bd, Duration: 7 Days | | 2 | Comparator Arm | Procedure | - | kavalaH, कवलः | (Procedure Reference: Ashtang Hridyaya Sutrasthan 22/12, Procedure details: Taking sufficient amount of medicated fluid in mouth such that the fluid can be moved in mouth is called as kavala.)
(1) Medicine Name: Triphala Kwatha, Reference: Bharat Bhaishajya Ratnakar, Kashaya Prakarana, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 60(ml), Frequency: bd, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients having symptoms of posterior wall congestion, difficulty in swallowing, throat pain. Patients having fever, anorexia, headache. |
|
| ExclusionCriteria |
| Details |
Lower respiratory tract infected patients
Patients having tuberculosis |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Deacrease in symptoms of posterior wall congestion, difficulty in swallowing, fever, throat pain, anorexia, hwadache, drooling. |
3 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Decrease in symptoms of congestion, throat pain, difficulty in swallowing, headache |
7 days |
|
|
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)
|
30/07/2024 |
| 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="6"
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
|
The study will be intervened by the treatment of Sariva Kwatha Kawala and Triphala Kwatha Kawala to group A and group B respectively. The efficacy of the therapy will be assessed on the
basis of subjective criteria for statistical analysis. Scoring will be designed according to the severity
of symptoms. The subjective gradation of symptoms will be done as follows and the intensity of
each symptom will be calculated before treatment, after treatment and after follow up. The effect of
treatment result will be assessed in regards to clinical signs and symptoms on the basis of grading
and scoring system. The signs and symptoms will be assessed by adopting the suitable scoring
method. |