CTRI/2024/06/068877 [Registered on: 13/06/2024] Trial Registered Prospectively
Last Modified On:
09/04/2026
Post Graduate Thesis
Yes
Type of Trial
Interventional
Type of Study
Drug Ayurveda Other (Specify)
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
Effect of Ghana vati and Mouthwash in Tundikeri (Tonsillitis)
Scientific Title of Study
Evaluation of efficacy of Patola-Katurohinyadi Ghana vati and Panchavalkaladi mouthwash in the management of Tundikeri (Tonsillitis)-An Open labelled two arm Randomised Contolled Trial
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
NIL
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Priyanka Yadav
Designation
PG Scholar
Affiliation
All India Institute of Ayurveda
Address
5th floor academic block,Department of Shalakya Tantra, All India Institute of Ayurveda, South Delhi, 110076,India
South West DELHI 110076 India
Phone
8058721398
Fax
Email
027yadavpriyanka@gmail.com
Details of Contact Person Scientific Query
Name
Dr Manjusha Rajagopala
Designation
HoD & Professor
Affiliation
All India Institute of Ayurveda
Address
5th floor academic block,Department of Shalakya Tantra, All india institute of Ayurveda, South Delhi, 110076,India
South West DELHI 110076 India
Phone
9560788850
Fax
Email
bhatrajma2008@gmail.com
Details of Contact Person Public Query
Name
Dr Manjusha Rajagopala
Designation
HoD & Professor
Affiliation
All India Institute of Ayurveda
Address
5th floor academic block,Department of Shalakya Tantra, All india institute of Ayurveda, South Delhi, 110076,India
South West DELHI 110076 India
Phone
9560788850
Fax
Email
bhatrajma2008@gmail.com
Source of Monetary or Material Support
All India Institute of Ayurveda, mathura road, Gautampuri,sarita vihar, new delhi, 110076
Primary Sponsor
Name
All India Institute of Ayurveda
Address
Mathura Rd,Gautampuri,Sarita vihar, New Delhi, 110076
Type of Sponsor
Research institution and hospital
Details of Secondary Sponsor
Name
Address
nil
nil
Countries of Recruitment
India
Sites of Study
No of Sites = 1
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Priyanka Yadav
All India Institute of Ayurveda
OPD No.102,(SHALAKYA TANTRA , ENT OPD),1st floor, hospital block,Mathura Rd, Gautampuri, Sarita vihar, South DELHI South West DELHI
8058721398
027yadavpriyanka@gmail.com
Details of Ethics Committee
No of Ethics Committees= 1
Name of Committee
Approval Status
All India institute of Ayurveda, Institutional Ethics Committee
(Procedure Reference: bhavprakash, Procedure details: patient is asked to hold the liquid sol in their mouth to its full capacity, tilt the head slightly upwards,hold the liquid for 3-5 min, till kapola becomes full of kapha secretions, till secretion starts in nasa and netra, split out the liquid)
4
Intervention Arm
Procedure
-
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(Procedure Reference: bhavprakash, Procedure details: patient asked to hold liquid in their mouth to its full capacity, tilt the head slightly upwards, hold the liquid in your mouth till 3-5 min, till kapola becomes full of kapha secretions, till secretions starts in nasa and netra.)
Inclusion Criteria
Age From
10.00 Year(s)
Age To
40.00 Year(s)
Gender
Both
Details
patients having signs and symptoms of tundikeri,patients aged between 10-40 years, patients who are willing to participate in the study
ExclusionCriteria
Details
patient with complications of Tonsillitis like Peritonsillar abscess, parapharyngeal abscess,Malignancy, Syphilis, and TB presenting as tonsillar disease. Immuno-compromised patients like HIV, SLE, multiple myeloma, Cancer etc. Patients having systemic diseases like diabetes, hypertension, thyroid dysfunction
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Not Applicable
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
1.Changes in Sign and Symptoms of Tundikeri i.e.Congestion and Dysphagia
42 days
Secondary Outcome
Outcome
TimePoints
Changes in sign and symptoms of Tundikeri (Tonsillitis) i.e Fever, Pain, Size of tonsils,burning sensation, halitosis,white pus filled follicles on tonsils, lymph node enlargement. Changes in haematological parameters
42 days
Target Sample Size
Total Sample Size="30" Sample Size from India="30" Final Enrollment numbers achieved (Total)= "60" Final Enrollment numbers achieved (India)="60"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
Tonsillitis or inflammation of the tonsils is a common disease and makes up appx. 1.3% of outpatient visits. It is rare in infants and in persons who are above 50 years of age.(1)
It may be viral or bacterial. Clinical features are sore throat, dysphagia, earache, hyperemia of pillars, soft palate, and uvula, enlarged and tender cervical lymph nodes, pyrexia, etc. The treatment may include plenty of fluids, analgesics, and antimicrobial therapy. If not managed properly and on time, may lead to chronic tonsillitis, peritonsillar abscess, cervical abscess, acute otitis media, etc.
Chronic tonsillitis may be a complication of acute tonsillitis. Mostly it affects children and young adults and rarely occurs after 50 years. Chronic infection in sinuses or teeth may be a predisposing factor (2). The Clinical features include recurrent attacks of sore throat with the cough, halitosis, dysphagia, and choking spells at night. Conservative treatment consists of orientation to general health with treatment of co-existent factors of teeth, nose, and sinuses. Tonsillectomy is indicated when tonsils interfere with speech, deglutination, and respiration(3).
The clinical features of Tundikeri explained in the classics are similar to Tonsillitis.. Acharya Shushruta considered Tundikeri as Talugata Roga and Acharya Vagbhatt mentioned it in Kanthagata Roga under the heading of Mukha Roga. Tundikeri is due to vitiation of Kapha-Rakta ,there is manifestation of Shopha near Talu or Hanusandhi which resemble like Karpasa Phala and having characteristics like Shotha,Toda, Daha,Prapaka, Pichhila, Mandaruja etc .All drugs should have properties like Lekhana, Shothhara, Sandhaniya, Ropana, Rakt stambhaka and Vedana sthapana..
Patoladi gana is mentioned in Ashtang hridya in ShodhanadiGana sanghrahadhyay which consists of Patola, Katurohini, Madhusrav, Chandana, Guduchi, and Patha (4). Almost all ingredients are rakta-prasadak kapha, pittaghna. Ghana vati is made to mask the distaste. This ghana vati is easy to administer. Few works have been done on various aspects of Tundikeri, no study have been found on Patola katurohinyadi ghana vati. Thus an attempt has been made attempt to study its efficacy in Tundikeri .