| CTRI Number |
CTRI/2026/01/100989 [Registered on: 13/01/2026] Trial Registered Prospectively |
| Last Modified On: |
08/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study work to see Effectiveness of Dashamoola Hareetaki Avaleha, Darvyadi Kwatha and Jatyadi Gutika in the treatment of Chronic tonsillitis |
|
Scientific Title of Study
|
A RANDOMIZED COMPARATIVE CLINICAL TRIAL TO EVALUATE THE EFFICACY OF DASHAMOOLA HAREETAKI AVALEHA AND DARVYADI KWATHA ALONG WITH JATYADI GUTIKA IN TUNDIKERI WITH SPECIAL REFERENCE OF CHRONIC TONSILLITIS |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sanjiv kumar |
| Designation |
PG scholar,depatment of shalakya tantra |
| Affiliation |
National Institute of Ayurveda,Deemed To Be University (De-novo) |
| Address |
Room number 314,Depatment of Shalakya tantra,academic
block,National Institute of Ayurveda,Deemed To Be University (De-novo),
Jorawar Singh Gate ,Amer Road, Jaipur ( Raj.)-302002
Jaipur
RAJASTHAN
302002
India |
| Phone |
8839584110 |
| Fax |
|
| Email |
drgsanjive@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Aparna Sharma |
| Designation |
MS(AYU),PhD,Professor |
| Affiliation |
National Institute of Ayurveda,Deemed To Be University (De-novo) |
| Address |
Room number 314,Depatment of Shalakya tantra,academic
block,National Institute of Ayurveda,Deemed To Be University (De-novo),
Jorawar Singh Gate ,Amer Road, Jaipur ( Raj.)-302002
Jaipur
RAJASTHAN
302002
India |
| Phone |
8955688129 |
| Fax |
|
| Email |
appu07@gamil.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjiv kumar |
| Designation |
PG scholar |
| Affiliation |
National Institute of Ayurveda,Deemed To Be University (De-novo) |
| Address |
Room number 314,Depatment of Shalakya tantra,academic
block,National Institute of Ayurveda,Deemed To Be University (De-novo),
Jorawar Singh Gate ,Amer Road, Jaipur ( Raj.)-302002
Jaipur
RAJASTHAN
302002
India |
| Phone |
8839584110 |
| Fax |
|
| Email |
drgsanjive@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda,jaipur |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda,jaipur |
| Address |
National Institute of Ayurveda,Deemed To Be University (De-novo),
Jorawar Singh Gate ,Amer Road, Jaipur ( Raj.)-302002
|
| Type of Sponsor |
Research institution and hospital |
|
|
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 sanjive |
National Institute of Ayurveda |
opd num 13 PG department of shalakya tantra, jorawae singh gate,amer road,jaipur rajasthan jaipur RAJASTHAN
Jaipur
RAJASTHAN |
8839584110
drgsanjive@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONALETHICS COMMITTEE NATIONAL INSTITUTE OF AYURVEDA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J350||Chronic tonsillitis and adenoiditis. Ayurveda Condition: TUNDIKERI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Dashmoola Hareeaki Avaleha, Reference: Ashtangahrdaya, , Chikitsasthan Adhyaya 17:14-16 , Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Antarabhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: Jatyadi Gutika, Reference: GADANIGRAH, MUKHA ROGA, BHARAT BHAISHAJAYA RATNAKAR PART 2 SHLOKA- 2018), Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Antarabhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -water), Additional Information: It is a common medicine in both arm
| | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Darvyadi kwatha, Reference: Ashtanga Hridaya,Uttara sthan 54/22, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Antarabhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: Darvyadi kwatha will use as Kwatha 20 ml, bd and Gandoosha 20 ml bd (2) Medicine Name: Jatyadi Gutika, Reference: GADANIGRAH, MUKHA ROGA, BHARAT BHAISHAJAYA RATNAKAR PART 2 SHLOKA- 2018), Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Antarabhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -water), Additional Information: It is a common medicine in both arm |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Patients presenting with symptoms of Tundikeri(chronic tonsilities) as Shopha(Measurement of size of tonsils) Daha(Burning sensation in throat), Toda (Pricking pain), Galoparodha (Dysphagia), Halitosis (Bad Breath), Prapaka(Pus formation in Tonsils) ,Ragatawa (Congestion in anterior pillar and pharyngeal mucosa ),- Enlarged lymph nodes (Jugulodigastric lymph nodes) |
|
| ExclusionCriteria |
| Details |
1. Patients with peritonsillar abscess, parapharyngeal abscess, Acute Tonsillitis, Tonsillolath, Malignancy,3rd and 4th grade Tonsillitis.
2. Systemic disease like Diabetes mellitus ,Hypertention
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction of the Shotha (Swelling)according to Brodsky Grading Scale |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| : Improvement symptoms such as Daha(Burning sensation in throat), Toda (Pricking pain), Galoparodha (Dysphagia), Halitosis (Bad Breath), Prapaka(Pus formation in Tonsils) ,Ragatawa (Congestion in anterior pillar and pharyngeal mucosa ),- Enlarged lymph nodes (Jugulodigastric lymph nodes) |
30days |
|
|
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 |
|
Date of First Enrollment (India)
|
11/11/2026 |
| 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="0"
Months="1"
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
|
My research title is A RANDOMIZED COMPARATIVE CLINICAL TRIAL TO EVALUATE THE EFFICACY OF DASHAMOOLA HAREETAKI AVALEHA AND DARVYADI KWATHA ALONG WITH JATYADI GUTIKA IN TUNDIKERI WITH SPECIAL REFERENCE OF CHRONIC TONSILLITIS .. Tonsillitis is one of the most common inflammation of the throat which usually affects persons of the age group between 5-50 year .Tundikeri is considered to be one among the Mukharoga (disease of oral cavity )Tundikeri means Vanakarpas Phala (Gossypium herbacium Linn.). This Shotha looks like cotton fruit. Tundikeri is caused by vitiation of Kapha and Rakta.Aim of research is To compare the efficacy of Dashamoola Hareetaki Avaleha and Darvyadi Kwatha along with Jatydi Gutica in the management of Tundikeri W.S.R to Chronic Tonsillitis.Objectives are to evaluate the efficacy of Dashamoola Hareetaki Avaleha in Tundikeri along with Jatyadi Gutika, To evaluate the efficacy of Darvyadi Kwatha in Tundikeri along with Jatyadi Gutika.duration of trial is 30 days and duration of study is 18 months |