| CTRI Number |
CTRI/2025/07/091235 [Registered on: 21/07/2025] Trial Registered Prospectively |
| Last Modified On: |
19/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study efficacy of Triphala kwatha with madhu gandusha in the patients of Tundekeri |
|
Scientific Title of Study
|
A Randomized Open Labelled Controlled Clinical Study of Efficacy of Triphala Kwataha with Madhu Gandusha in Tundekeri with Special Reference to Acute Tonsilitis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sneha Vasant Patil |
| Designation |
PG scholar |
| Affiliation |
Siddhakala Ayurveda Mahavidyalaya Sangamner |
| Address |
Kaumarbhritya department Siddhakala Ayurveda Mahavidyalaya Pimparne road Sangamner Ahmadnagar 422605 Maharashtra India
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
7020800933 |
| Fax |
|
| Email |
drsneha008@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pramod Hase |
| Designation |
Professor Kaymarbhritya Department |
| Affiliation |
Siddhakala Ayurveda Mahavidyalaya Sangamner |
| Address |
Kaumarbhritya Department Siddhakala Ayurveda Mahavidyalaya Pimparne road Sangamner Ahmadnagar 422605 Maharashtra India
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
9960688468 |
| Fax |
|
| Email |
drpramodhase@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pramod Hase |
| Designation |
Professor Kaymarbhritya department |
| Affiliation |
Siddhakala Ayurveda Mahavidyalaya Sangamner |
| Address |
Kaymarbhritya department Siddhakala Ayurveda Mahavidyalaya Pimparne road Sangamner Ahmadnagar Maharashtra
422605
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
9960688468 |
| Fax |
|
| Email |
drparmodhase@gmail.com |
|
|
Source of Monetary or Material Support
|
| Siddhakala Ayurveda Mahavidyalaya Pimparne road Sangamner Ahmadnagar Maharashtra 422605 |
|
|
Primary Sponsor
|
| Name |
Sneha Vasant Patil |
| Address |
Siddhakala Ayurveda Mahavidyalaya Pimpari road Sangamner Pin code 422605 Ahmadnagar Maharashtra India |
| Type of Sponsor |
Other [Own] |
|
|
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 Pramod Hase |
Siddhakala Ayurveda Mahavidyalaya Sangamner |
Siddhakala Ayurveda Hospital Sangamner Koumarbhritya Department OPD no 4
Ahmadnagar
MAHARASHTRA |
9960688468
drpramodhase@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Board of Ayurveda research and statistics of committee of Siddhakala Ayurveda Mahavidyalaya Sangamner |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:B950||Streptococcus, group A, as the cause of diseases classified elsewhere. Ayurveda Condition: TUNDIKERI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | gaNDUShaH, गण्डूषः | (Procedure Reference: Sharangdhar samhita uttarkhand 10th adhyaya 1/10, Procedure details: The child should be force to seat in the room with comfort and upright posture
Triphala madhu kwatha has to be retained in his/her mouth to its full capacity without moving mouth
Individual should not engulf it
)
(1) Medicine Name: Triphala madhu Kwatha, Reference: Sharangdhar samhita uttarkhand 10 th adhyaya 13/10, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 20(ml), Frequency: bd, Duration: 7 Days | | 2 | Comparator Arm (Non Ayurveda) | | - | Povidone iodine 2% | Dose 10 ml twice a day
Duration 7 days |
|
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Patients of age group from 7 to 12 years of age
Patient presenting with tundekeri with only mild to moderate symptoms described in the context of tundekeri will be selected
Patient will be selected irrespective of sex caste socio economic status
|
|
| ExclusionCriteria |
| Details |
Patient having systemic disorders Bronchial Asthma Pneumonia Bronchiectasis Tuberculosis COPD Covid
Tonsillitis with high grade fever suppurative tonsilitis chronic tonsilitis with oral pathological conditions
Tonsilitis associated with respiratory distress benign tumor or malignancy tonsils tonsilar cyst Peritonsilar abscess
Patients having any malignancy suffering from immune compressive diseases[HbsAg HIV etc]
Patients below 7 years and above 12 years
Patinets having 7 to 8 episodes of tonsilitis fron previous year |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study in detail the efficacy of triphala kwatha with madhu gandusha in tundekeri with special reference to Acute tonsilitis in childern from 7 to 12 years of age |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To know the concept of Tundekeri from Ayurveda and modern aspectin childerns with 7 to 12 years of age
To study triphala kwatha gandusha and effects of it in details in tundekeri with 7 to 12 years of age |
7 days |
|
|
Target Sample Size
|
Total Sample Size="89"
Sample Size from India="80"
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 |
|
Date of First Enrollment (India)
|
30/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
30/07/2025 |
| 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
|
This study is randomized open labelled controlled clinical trial 80 patients taken for study 40 patients in each group to study efficacy of triphala kwath madhu gandusha in tundekeri with special reference to Acute tonsilitis |