| CTRI Number |
CTRI/2025/07/090098 [Registered on: 03/07/2025] Trial Registered Prospectively |
| Last Modified On: |
19/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Ayurvedic line of Management in adenoid enlargement in children. |
|
Scientific Title of Study
|
Effectiveness of selected Ayurveda management protocol in adenoid hypertrophy among children of age group 5 to 10 years. |
| 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 Musafar Ahammed |
| Designation |
PG Scholar Department of Shalakyatantra |
| Affiliation |
Government Ayurveda Medical College thiruvananthapuram kerala |
| Address |
Department of Shalakyatantra, Government Ayurveda college thiruvananthapuram Kerala. 695001.
Thiruvananthapuram
KERALA
695001
India |
| Phone |
9496952573 |
| Fax |
|
| Email |
musafarmarayi2016@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Musafar Ahammed |
| Designation |
PG Scholar Department of Shalakyatantra |
| Affiliation |
Government Ayurveda Medical College thiruvananthapuram kerala |
| Address |
Department of Shalakyatantra, Government Ayurveda college thiruvananthapuram Kerala. 695001.
Thiruvananthapuram
KERALA
695001
India |
| Phone |
9496952573 |
| Fax |
|
| Email |
musafarmarayi2016@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kusumam Joseph |
| Designation |
Professor, Department of Shalakyatantra |
| Affiliation |
Government Ayurveda Medical College Thiruvananthapuram |
| Address |
Department of Shalakyatantra, Government Ayurveda college thiruvananthapuram Kerala. 695001.
Thiruvananthapuram
KERALA
695001
India |
| Phone |
9446187163 |
| Fax |
|
| Email |
kusumamjoseph123@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurveda Medical College and Hospital Thiruvananthapuram. 695001 Kerala, India. |
|
|
Primary Sponsor
|
| Name |
Dr. Musafar Ahammed |
| Address |
PG Scholar. Department of Shalakyatantra, Government Ayurveda college thiruvananthapuram Kerala. 695001. |
| Type of Sponsor |
Other [Self] |
|
|
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 Musafar Ahammed |
Government Ayurveda Medical Hospital Thiruvananthapuram |
Department of Shalakyatantra, Government Ayurveda college Hospital thiruvananthapuram Kerala. 695001.
Thiruvananthapuram
KERALA |
9496952573
musafarmarayi2016@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE (IEC)Government Ayurveda College, Thiruvananthapuram Kerala India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J352||Hypertrophy of adenoids. Ayurveda Condition: NASAROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Varanadi Kashaya , Reference: Ashtang Hridaya sutrasthana 15/21,22, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 25(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 1 Months, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kanchanara guggulu tablet., Reference: Bhaishajya Ratnavali 44/64,69, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 1 Months, anupAna/sahapAna: No, Additional Information: - | | 3 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Vilwadi tab , Reference: Ashtang Hridaya Uttarasthana 36/84,85, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 0.4(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 1 Months, anupAna/sahapAna: No, Additional Information: - | | 4 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Saptamushtee yusha , Reference: Sharangdhara Samhita , Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 35(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 1 Months, anupAna/sahapAna: No, Additional Information: - | | 5 | Intervention Arm | Procedure | - | gaNDUShaH, गण्डूषः | (Procedure Reference: Ashtanga Hridaya , Procedure details: Gandusha is a procedure holding any medicated liquid in mouth to its full capacity for a specific time
without any movements inside the mouth. It can be done with Sneha dravyas, kashayas, ushnodaka,
madhu, mamsarasa, madya, etc, according to dosha.)
|
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed cases of adenoid hypertrophy with breathing difficulty.
Patients between age group 5 years to 10 years, irrespective of gender, religion, and socio-economic status. |
|
| ExclusionCriteria |
| Details |
Diagnosed cases of systemic disorders like renal and cardiac diseases
Diagnosed cases malignancy, TB, anemia and bleeding disorders.
Use of corticosteroids in all forms within 3 months of enrolment
Participants with Infectious adenoid hypertrophy.
Malnourished and underweight children.
Children with developmental delay |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the effect of Varanadi Kashaya, Kanchanara guggulu tablet, Vilwadi tablet
and Trikatukadi gandusha followed by Saptamushtika yusha pana and pathyahara and
vihara in reducing the symptoms in participants of age group of 5-10 years irrespective
of gender diagnosed with adenoid hypertrophy. |
0th,30th,60th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To critically study adenoid hypertrophy in an Ayurvedic perspective. |
0th,15th,30th, 60th day |
|
|
Target Sample Size
|
Total Sample Size="23"
Sample Size from India="23"
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 3 |
|
Date of First Enrollment (India)
|
04/08/2025 |
| 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 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
|
Adenoid hypertrophy is a condition characterized by obstruction of airway in the nasopharyngeal region by the enlarged adenoids. Adenoids gets hypertrophied with/without acute or chronic infection of the adenoid, obstructing the posterior nasal opening and respiratory, nasal and aural symptoms are shown. Even though the hypertrophy gets atrophied during puberty, it can create serious difficulties to the individual in the form of upper airway obstruction associated with, nasal block, mouth breathing, obstructive sleep apnea, hypopnea, and upper airway resistance syndrome (UARS) etc. At present Adenoidectomy is the only definite management available for Adenoid hypertrophy, which can cause aftereffects like recurrent respiratory infections and allergic reactions. Chances of regrowth is also up to 26% and recurrence of some symptoms are also reported in many cases. No conservative managements are available at present. So, an alternate management protocol is a necessity.The selected treatment protocol includes Varanadi Kashaya, Kanchanara guggulu tablet, Vilwadi tablet, Trikatukadi gandusham for one month followed by 1 month of pathyakala with Saptamushtika yusha panam which has kaphahara properties. 23 patients diagnosed with non-infectious adenoid hypertrophy of age group 5-10 years selected on the basis of inclusion criteria attending OPD and IPD of Shalakyatantra, Govt. Ayurveda College, Thiruvananthapuram will be subjected to the selected treatment protocol for 30 days followed by 1 month of pathya. Clinical evaluation will be done prior to the commencement of intervention, 15th day, 30th day and 60th day. Results will be statistically analyzed after the study by Kruskal-wallis test. |