| CTRI Number |
CTRI/2025/03/081796 [Registered on: 06/03/2025] Trial Registered Prospectively |
| Last Modified On: |
01/06/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda Screening |
| Study Design |
Other |
|
Public Title of Study
|
A clinical trial to study the effects of Rasnopakulyadi Kashaya and Rajanyadi churna in adenoid hypertrophy among children in the age group of 4 -12 years |
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Scientific Title of Study
|
Combined effect of Rasnopakulyadi Kashaya and Rajanyadi churna in adenoid hypertrophy in the age group of 4-12 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 |
ANEESHA FATHIMA S |
| Designation |
PG SCHOLAR |
| Affiliation |
Government Ayurveda college hospital, pariyaram p. o, Kannur, 670503 |
| Address |
Room no. 8, Shalakyatantra OPD, Government ayurveda college, Pariyaram P. O, kannur
Kannur KERALA 670503 India |
| Phone |
8075876759 |
| Fax |
|
| Email |
aneeshafathima99@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Ambili k |
| Designation |
Associate professor, Shalakyatantra department, government ayurveda college, kannur. |
| Affiliation |
Government Ayurveda college hospital, pariyaram p. o, Kannur, 670503 |
| Address |
Room no. 8, Shalakyatantra OPD, Government ayurveda college, Pariyaram P. O, kannur
Kannur KERALA 670503 India |
| Phone |
9446028794 |
| Fax |
|
| Email |
amlikavinal@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Aneesha Fathima. S |
| Designation |
Pg Scholar, Government ayurveda college, pariyaram p. o, kannur, 670503 |
| Affiliation |
Government Ayurveda college hospital, pariyaram p. o, Kannur,670503 |
| Address |
Room no. 8, Shalakyatantra OPD, Government ayurveda college, Pariyaram P. O, kannur
Kannur KERALA 670503 India |
| Phone |
8075876759 |
| Fax |
|
| Email |
aneeshafathima99@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government ayurveda college, pariyaram p. o, Kannur, 670503 |
|
|
Primary Sponsor
|
| Name |
Government ayurveda college pariyaram p O kannur |
| Address |
Room no. 8, Shalakyatantra OPD, Government ayurveda college, pariyaram p. o, kaanur |
| Type of Sponsor |
Other [SELF] |
|
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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 Aneesha Fathima S |
Hospital |
Room no. 8, Shalakyatantra opd, government Ayurveda college, pariyaram p.o, kannur Kannur KERALA |
8075876759
aneeshafathima99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government ayurveda college, pariyaram p. o, kannur |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O||Medical and Surgical. Ayurveda Condition: KANTHAGATAROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Rasnopakulyadi kashayam, Reference: Arogya kalpa drumam, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 24(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Sita), Additional Information: Nil(2) Medicine Name: Rajanyadi Choorna , Reference: Ashtanga hridaya , Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Madhu, ghrita), Additional Information: Nil | | 2 | Intervention Arm | Drug | - | | |
|
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Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Participants in the age group of 4-12 years irrespective of gender.
Participants diagnosed with adenoid hypertrophy within 1 month by X - ray, CT or Diagnostic Nasal Endoscopy (DNE).
Participants with at least any one of the symptoms of adenoid hypertrophy such as,
Mouth breathing
Snoring
Sleep apnea (grade 1 and 2)
Nasal obstruction
Participants who are willing to give informed assent and parents’s consent. |
|
| ExclusionCriteria |
| Details |
Participants suffering from other systemic illness
Participants who underwent conservative management for adenoids during the last 3 months.
Participants with complications of adenoid hypertrophy like otitis media, chest infection.
Children with body temperature above 99 degree Fahrenheit.
Participants with any other local or systemic illness other than grade 1 and grade2 tonsillar hypertrophy. |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Mouth breathing
Snoring
Sleep apnea
Nasal obstruction |
1year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not applicable |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="26" Sample Size from India="26"
Final Enrollment numbers achieved (Total)= "26"
Final Enrollment numbers achieved (India)="26" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/04/2025 |
| Date of Study Completion (India) |
06/12/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The adenoid is a mass of lymphoid tissue located in the nasopharynx, responsible for producing antibodies. However, adenoid hypertrophy, a common condition where the adenoid becomes enlarged, can lead to nasal obstruction, resulting in sleep disorders such as snoring and sleep apnea. This, in turn, can cause educational and social problems. Chronic nasal obstruction and mouth breathing can also lead to adenoid facies, characterised by an elongated face, crowded teeth, and a pinched nose. If left untreated, complications such as middle ear infections, glue ear infections, and chest infections may occur. Fortunately, management options are available, including breathing exercises, decongestant nasal drops, steroid nasal spray, antihistamines, and, in severe cases, adenoidectomy, the surgical removal of the adenoid. However, these medical treatments provide only temporary relief, and surgical intervention is not always preferred in paediatric practice. Hence, a pre and post-clinical trial was conducted on 26 participants aged 4-12 years, irrespective of gender, diagnosed with adenoid hypertrophy within 1 month by X-ray, CT or Diagnostic Nasal Endoscopy (DNE) at the Shalakyatantra OPD, Govt. Ayurveda College, Kannur. Participants received study medications in age-appropriate doses with the necessary instructions. Assessment of symptoms such as mouth breathing, snoring, sleep apnoea, and nasal obstruction was carried out at baseline (Day 0), on the 15th and 31st days, and at follow-up on the 45th and 61st days. Data were analysed using the Friedman test, followed by post hoc analysis with the Durbin–Conover test. The results revealed that symptoms such as mouth breathing, snoring, and nasal obstruction had statistically significant improvement (p < 0.001) following treatment, and no cases of sleep apnoea were observed during the study period. The requirement for nasal spray use was markedly reduced during treatment, and most participants remained symptom-free even at follow-up, indicating sustained therapeutic benefits.
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