| CTRI Number |
CTRI/2025/06/089664 [Registered on: 27/06/2025] Trial Registered Prospectively |
| Last Modified On: |
25/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Ayurvedic management of hypertrophied adenoids in children. |
|
Scientific Title of Study
|
Clinical study to evaluate the combined effect of apamarga kshara taila prathimarsha nasya and oral administration of kumarabharana rasa in the management of hypertrophied adenoids in children. |
| 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. Chandana Lakshmi |
| Designation |
PG Scholar |
| Affiliation |
Sri dharmastala manjunatheshwara college of ayurveda and hospital thanneruhalla bm road hassan. |
| Address |
Sri dharmastala manjunatheshwara college of ayurveda and hospital thanneruhalla bm road hassan.
kaumarabhritya dept 2nd floor of college building
Hassan KARNATAKA 573201 India |
| Phone |
9901709928 |
| Fax |
|
| Email |
pg22120@sdmcahhassan.org |
|
Details of Contact Person Scientific Query
|
| Name |
Dr.Vijaya laxmi mallannavar |
| Designation |
Associate professor |
| Affiliation |
Sri dharmastala manjunatheshwara college of ayurveda and hospital thanneruhalla bm road hassan. |
| Address |
Sri dharmastala manjunatheshwara college of ayurveda and hospital thanneruhalla bm road hassan.
Hassan KARNATAKA 573201 India |
| Phone |
9480624829 |
| Fax |
|
| Email |
abtittu@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr.Vijayalaxmi mallannavar |
| Designation |
Associate professor |
| Affiliation |
Sri dharmastala manjunatheshwara college of ayurveda and hospital thanneruhalla bm road hassan. |
| Address |
Sri dharmastala manjunatheshwara college of ayurveda and hospital thanneruhalla bm road hassan.
kaumarabhritya dept 2nd floor of college building
Hassan KARNATAKA 573201 India |
| Phone |
9480624829 |
| Fax |
|
| Email |
abtittu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri dharmastala manjunatheshwara college of ayurveda and hospital thanneruhalla bm road hassan-573201 karnataka India |
|
|
Primary Sponsor
|
| Name |
Sri dharmastala manjunatheshwara college of ayurveda and hospital thanneruhalla bm road hassan |
| Address |
Sri dharmastala manjunatheshwara college of ayurveda and hospital thanneruhalla bm road hassan 573201 karnataka
Sri dharmastala manjunatheshwara college of ayurveda and hospital thanneruhalla bm road hassan 573201 karnataka 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 |
| DrChandana Lakshmi |
Sri dharmastala manjunatheshwara college of ayurveda and hospital thanneruhalla bm road hassan. |
Sri dharmastala manjunatheshwara college of ayurveda and hospital thanneruhalla bm road hassan.department of kaumarabhritya opd 16 Hassan KARNATAKA |
9901709928
pg22120@sdmcahhassan.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITEE SRI DHARMASTALA MANJUNATHESHWARA COLLEGE OF AYURVEDA AND HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J352||Hypertrophy of adenoids. Ayurveda Condition: KANTHASALUKAH/TUNDIKERI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | nasyam/ nastam, नस्यम्/ नस्तम् | (Procedure Reference: astanga hridaya uttara tantra 21 st chapter, Procedure details: prathimarsha nasya with apamarga kshara taila 2 drops to each nostril twice daily mormimg & evening ) (1) Medicine Name: apamarga kshara taila, Reference: astangahridaya uttara tantra 21 chapter and afi, Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 2(drops), Frequency: bd, Duration: 30 Days | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: kumarabharana rasa, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: honey), Additional Information: new drug not mentioned in any classical ayurvedic text |
|
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
.Subject of age group 3-8 years of either sex who fulfill the diagnostic criteria
2.The subject whose parents are willing to participate their child in the study and ready to
sign the consent form
|
|
| ExclusionCriteria |
| Details |
Subject associated with fever.
2.Subject associated with nasal polyp and nasal bleeding.
3.Subject with any other systemic illness.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| reduction in nasal obstruction,mouth breathing, snoring ,reduction in size of adenoids |
0th day (BT) 15th day (DT) 30th day (AT) 15th day (FU) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
impact on health status
reduction in recurrent infection
improvement in sleep |
0th day (BT) 15th day (DT) 30th day (AT) 15th day (FU) |
|
|
Target Sample Size
|
Total Sample Size="20" Sample Size from India="20"
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
|
N/A |
|
Date of First Enrollment (India)
|
20/07/2025 |
| 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="6" 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [chandanalakshmi999@gmail.com].
- For how long will this data be available start date provided 01-01-2026 and end date provided 31-12-2026?
Response (Others) - one year post to publication
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Respiratory
diseases are the greatest cause of pediatric medical visits, nasal obstruction is most common.1Adenoid hypertrophy(AH) is an obstructive
condition due to increased size of adenoids2. Adenoids being a part
of immune system and act as the first line of defence mechanism of
aerodigestive tract3, they can get inflamed and enlarged by allergy
of upper respiratory tract recurrent
attacks of rhinitis , sinusitis or
chronic tonsilitis4..
Adenoid
hypertrophy occupies the most among all diseases of the upper respiratory tract
in paediatric, accounting for about 34.5% according to NCBI a systematic review
and Metaanalysis5. 0-75% adenoids enlargement is diagnosed at 3-10 years. The
symptoms of adenoid hypertrophy tend to occur more among young children,
because of the increased frequency of upper respiratory tract infections and
the small volume of the nasopharynx. Even though
this condition is generally self-resolving due to age-related adenoid
atrophy, AH can lead to a series of
serious complications including sleep-disordered breathing and sleep
apnea which in children can lead to growth failure,
and neurocognitive abnormalities such as low intelligence quotient, learning
and behavioral problems, poor attention span,ear infections, temporary hearing
loss and Pulmonary hypertension6.
The
treatment options available for adenoid
hypertrophy are antibiotics, antihistamines
, nasal steroidsand surgical management called adenoidectomy may result in
postoperative complications such as immediate and late bleeding (0.7%)7
,vomiting ,difficulties in swallowing
and pain .recurrence of adenoid tissue is 20% The risk of adenoid re-growth is slightly more
common in patients who undergo adenoidectomy at a young age8.The
complications arising from the medical and surgical management makes us to find
out the alternative line of management with no added adverse effect .
In
Ayurveda, adenoid enlargement can be well correlated with Kanthashaluka9owing
to the marked similarities of the clinical presentations of hypertrophied
adenoids like margarodha,kolavath granti10.As it is an urdhwajatrugatavikara
and nasya is widely adopted and effective treatment modalityfor the management11,
in the present study pratimarshanasya is taken as choice of intervention . As
the disease is kaphapradhana the drug of choice should have,katu rasa,ushnateekshna
guna12hence apamargataila is selected for pratimarshanasya and kumarabharana
tablet internally.
As apamarga is having katutikta rasa
ushnaveerya,shodana and ropana property, it is taken as drug of choice and Kumarabharana Rasa
is Anubhuta Yoga (formulation) which is very effective in management of chronic
respiratory diseases especially in children as it is observed during the
clinical practice13 .Hence in the present study an attempt is made
to evaluate the combined effect of prathimarshanasya with apamargaksharatailaand
kumarabharana tablet internally in hypertrophied adenoids |