| CTRI Number |
CTRI/2024/10/075026 [Registered on: 10/10/2024] Trial Registered Prospectively |
| Last Modified On: |
04/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Treatment of Tonsillitis by Ayurvedic medicine Vachadi decoction, Pippalyadi churana and Kanchanar Guggulu tablet. |
|
Scientific Title of Study
|
Comparative clinical study to evaluate the efficacy of Vachadi Kwath Kaval and Pippalyadi Churna Pratisaran along with Kanchanar Guggulu in Tundikeri (Tonsillitis) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shaweta |
| Designation |
PG Scholar |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
| Address |
OPD 3, Department of Shalakya-Tantra, Patanjali ayurved hospital,
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Phase
1, Roorkee road, Haridwar, Uttarakhand, India 249405
Hardwar
UTTARANCHAL
249405
India |
| Phone |
8360035380 |
| Fax |
|
| Email |
shaweta830@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Jyoti Gupta |
| Designation |
Professor |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
| Address |
OPD 3, Department of Shalakya-Tantra, Patanjali ayurved hospital,
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Phase
1, Roorkee road, Haridwar, Uttarakhand, India 249405
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9997907340 |
| Fax |
|
| Email |
jyotiguptania@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shaweta |
| Designation |
PG Scholar |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
| Address |
OPD 3, Department of Shalakya-Tantra, Patanjali ayurved hospital,
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Phase
1, Roorkee road, Haridwar, Uttarakhand, India 249405
Hardwar
UTTARANCHAL
249405
India |
| Phone |
8360035380 |
| Fax |
|
| Email |
shaweta830@gmail.com |
|
|
Source of Monetary or Material Support
|
| Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Yogpeeth phase-1, Roorkee Road, Haridwar, Uttarakhand, India-249405 |
|
|
Primary Sponsor
|
| Name |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
| Address |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan,
Haridwar, Uttarakhand -249405
|
| 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 |
| Shaweta |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
OPD 3, Department of Shalakya-Tantra, Patanjali ayurved hospital,
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Phase
1, Roorkee road, Haridwar, Uttarakhand, India 249405
Hardwar
UTTARANCHAL |
08360035380
shaweta830@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Haridwar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K00-K14||Diseases of oral cavity and salivary glands. Ayurveda Condition: TUNDIKERI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | kavalaH, कवलः | (Procedure Reference: BH.R. 61/54, Procedure details: Patient will be advised to hold sufficient quantity of decoction which can be moved in the oral cavity. then patient will be instructed to move the medication in the mouth till it fills with the Vitiated doshas along with watering from nose, eyes & the effect of medicine gets neutralized. After the stipulated time patient will be instructed to spit out the medication. Same procedure will be repeated for 3-5-7 times according to strength of patient. This procedure will be done for 10 days. )
(1) Medicine Name: Kanchanar Guggulu, Reference: BH.R. 44/64-68, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Duration: 1 Months | | 2 | Comparator Arm | Procedure | - | pratisAraNam, पà¥à¤°à¤¤à¤¿à¤¸à¤¾à¤°à¤£à¤®à¥ | (Procedure Reference: Chakradutta 56/17, Procedure details: 1. Patient will be made to sit on the soft cushion chair in straight posture.
2. Patient will be asked to open his/ her mouth widely & the tongue depressor will be applied over the dorsum of posterior 1/3rd of tongue.
3. Lignocaine 10% spray will be used to reduce the sensitivity of Oro-pharynx & to prevent gag reflex.
4. Cotton ball will be held in a long artery forcep and gently rub over the anterior surface of the tonsils.
5. Pippalyadi Churna will be made into the paste form with honey. Apply the paste over the inflamed tonsils for till the achievement of Samyak lakshanas (as per sharangdhar Samhita).
6. During procedure, the patient will be asked to close the mouth and breathe comfortably, then the medicine will be removed with a cotton ball holding long forcep.
7. Pratisarana will be done once in a day till the samyak lakshanas are achieved up to 10 days))
(1) Medicine Name: kanchanar Guggulu, Reference: BH.R. 44/64-68, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Duration: 1 Months |
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients from 5 to 40 years of age of either sex.
2. Patients presenting with classical signs and symptoms of tundikeri (tonsillitis).
3. Patients willing to participate in this trial through written informed consent. |
|
| ExclusionCriteria |
| Details |
1. Patients below 5 and above 40 years of age.
2. Patients not willing for trial.
3. Patients suffering from any other major systemic diseases like diabetic mellitus,
hypertension, cancer, heart diseases.
4. Patients associated with peritonsillar abscess, parapharyngeal abscess, tonsillar
cyst, tonsillolith etc. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Routine blood investigations will be carried out
for all enrolled patients- CBC, ESR, RBS.
Assessment will be done on the basis of subjective and objective parameters |
Before and after treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment will be done on the basis of subjective and objective parameters. |
Before and after treatment |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
15/10/2024 |
| Date of Study Completion (India) |
22/09/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
This study is a Clinical Evaluation of Vachadi kwath Kaval and Pipplayadi Churna Pratisaran along with Kanchanar Guggul orally in Tundikeri (Tonsillitis). This will be conducted on 60 patients from OPD/IPD of Shalakya - Tantra Department of Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Haridwar. Patients will be divided into two groups - 30 patients will be given Vachadi Kwath Kaval along with Kanchanar Guggul orally and other 30 patients will be given Pippalyadi Churna Pratisaran along with Kanchanar Guggul orally. First follow up will be done 15 days after the treatment and second follow up will be done after 15 days of first follow up. Assessment will be done on the basis of subjective and objective parameters as discussed earlier. |