| CTRI Number |
CTRI/2024/07/070234 [Registered on: 09/07/2024] Trial Registered Prospectively |
| Last Modified On: |
03/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Management Of Pharyngitis With Kawal Of Darvyadi Decoction and Laxmivilas Rasa |
|
Scientific Title of Study
|
Management Of Pharyngitis With Kawal Of Darvyadi Decoction and Laxmivilas Rasa- An Open Labeled Single Arm Clinical Trial |
| 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 Shital Baraiya |
| Designation |
Assistant Professor |
| Affiliation |
Noble University |
| Address |
B-107, Shalakya Tantra Opd
Noble Ayurved College & Research Institute, Noble University,Bheshan Road, Junagadh
Junagadh
GUJARAT
362001
India |
| Phone |
9537350580 |
| Fax |
|
| Email |
shitalbaraiya0.sb@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr satishchandra Jaiswal |
| Designation |
Professor |
| Affiliation |
Noble University |
| Address |
Noble Ayurved College & Research Institute
Parth vatika
near Bamangam
Bheshan Road
Junagadh
Junagadh
GUJARAT
362001
India |
| Phone |
09323696244 |
| Fax |
|
| Email |
drjaiswalsatishchandra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr satishchandra Jaiswal |
| Designation |
Professor |
| Affiliation |
Noble University |
| Address |
Noble Ayurved College & Research Institute
Parthvatika
near Bamangam
Bheshan Road
Junagadh
GUJARAT
362001
India |
| Phone |
09323696244 |
| Fax |
|
| Email |
drjaiswalsatishchandra@gmail.com |
|
|
Source of Monetary or Material Support
|
| Noble Ayurved College and Research Institute, Noble University, Parth Vatika, Bhesan road, near Bamangam, Junagadh- 362001, Gujarat, India |
|
|
Primary Sponsor
|
| Name |
Noble Ayurved College and Research Institute |
| Address |
Noble University,Parth vatika
Bhesan Road
Near Bamangam
Junagadh- 362001
State- gujarat, India |
| 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 Shital Baraiya |
Noble Ayurved College and Research Institute |
B-107, Shalakya Tantra OPD, Noble Ayurved College & Research Institute, Noble University, Parth Vatika, Near bamangam, Bhesan road, Junagadh- 362001
Junagadh
GUJARAT |
9537350580
shitalbaraiya0.sb@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Noble Homeopathic College and Research Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:B978||Other viral agents as the cause ofdiseases classified elsewhere. 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, Procedure details: 1. Purva Karma:
Sambharsangraha : Darvyadi decoction, Boiled water, glass
2. Pradhana Karma:
Add 2 spoon of darvyadi decoction in 1 glass of boiled water & mix it well.
This lukewarm solution will be holded in the mouth. Then make it move briskly inside and spitting out quickly.
3.PaschatKarma:
Patient will be advised to do kawal 2 times per day for 21 days.
)
(1) Medicine Name: Darvyadi decoction, Reference: A.H.U.22/55, Route: Topical, Dosage Form: Kwatha/Kashaya, Dose: 30(ml), Frequency: bd, Duration: 15 Days | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Laxmivilas Rasa, Reference: Bhaishjya Ratnavali, Route: Oral, Dosage Form: Rasayoga, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
The patient willing to join this research work on Pharyngitis
The person with age of 12 – 80 years of either sex
The patients having specific symptoms of Pharyngitis
|
|
| ExclusionCriteria |
| Details |
A person with age below 12years.
A person with age above 80 years.
A person who has ongoing treatment of Pharyngitis will be excluded.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the efficacy of Kaval of Darvyadi decoction & Laxmivilas Rasa in sign & symptoms like Sore throat, difficulty in swallowing, coughing, fever |
till 1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To find out the Ayurvedic treatment modality for ‘Pharyngitis’
to access reduction in sign & symptoms of pharyngitis like Sore throat, difficulty in swallowing, coughing, fever by Ayurvedic treatment |
6 months, till 1 year |
|
|
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 3 |
|
Date of First Enrollment (India)
|
15/07/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
We
can say Ayurvedic Chikitsa is unique & complete which are mentioned in Ayurveda texts.
Acharya Vagbhatta has described Raktmokshan, Nasya, Kawal,
Pratisaran, Lepa and various internal medication for Kantha Roga. Here In this
disease Kapha And vata Dushti is mainly present. So mainly Kapha & Vatahar
Drug is selected for treatment.
There
are many formulations for Kaval is mentioned in various texts of Ayurveda.
But here Darvyadi Kwath Kaval is preferred for treatment due to its
Kapha-Vathar property.
Laxmivilas Rasa
has been used to treat wide range of diseases of upper respiratory tract,
abdominal conditions and some major systemic disorders such as anemia,
diabetes, tuberculosis, hepatitis and infertility. Thus it has broad spectrum
activity for the management of Kapha Vataj disorders. So here it is preferred
for treatment due to its Kapha-Vathar property. |