| CTRI Number |
CTRI/2022/07/043629 [Registered on: 01/07/2022] Trial Registered Prospectively |
| Last Modified On: |
27/06/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Ayurveda management of Pratishyaya in children |
|
Scientific Title of Study
|
Clinical study to evaluate the effect of oral administration of Tulasi Arka on Pratishyaya (Rhinitis) in children |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anjali |
| Designation |
Post graduate scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan |
| Address |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital
Thanniruhalla, Hassan
Hassan
KARNATAKA
573201
India |
| Phone |
7795625140 |
| Fax |
|
| Email |
anj3126@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijayalaxmi Mallannavar |
| Designation |
Associate Professor |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan |
| Address |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital
Thanniruhalla, 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 Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan |
| Address |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital
Thanniruhalla, Hassan
KARNATAKA
573201
India |
| Phone |
9480624829 |
| Fax |
|
| Email |
abtittu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan |
|
|
Primary Sponsor
|
| Name |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan |
| Address |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan |
| Type of Sponsor |
Private medical college |
|
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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 Anjali |
SDM College of Ayurveda and Hospital |
Room no.16, Department of Kaumarabhritya
Hassan
KARNATAKA |
7795625140
anj3126@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SDM College of Ayurveda and Hospital, Hassan |
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:J069||Acute upper respiratory infection,unspecified. Ayurveda Condition: PRATISYAYAH/PINASAH, (2) ICD-10 Condition: J309||Allergic rhinitis, unspecified, (3) ICD-10 Condition: J308||Other allergic rhinitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Tulasi Arka |
Orally administration.
2-4 years - 3ml, three times in a day for 7 days.
5-6 years - 5ml, three times in a day for 7 days. |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
1. Children between the age group of 2-6 years.
2. Children with Pratishyaya of recent onset within one week.
3. Children irrespective of gender, religion and socio-economic status fulfilling the diagnostic criteria.
|
|
| ExclusionCriteria |
| Details |
1. Congenital anomalies related to respiratory system.
2. Lower respiratory tract infection.
3. Jwara(>100oF)
4. Dushtapratishyaya, Raktapratishyaya and Sannipatajapratishyaya.
5. Chronic rhinitis, Sinusitis, Asthma, Infectious diseases like T.B. and other systemic disorders which interfere during the course of treatment.
|
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in symptoms of Pratishyaya like Nasasrava, Kshvathu, Ghranoparodha,Jwara, Kasa etc |
Tulasi Arka orally administrated for 7 days & Response of drug compound will be assessed on 0, 4th & 8th day. Follow up assessment will be done on 14th day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Patient well being,symptoms of Pratishyaya are reduced. |
Tulasi Arka orally administrated for 7 days & Response of drug compound will be assessed on 0, 4th & 8th day. Follow up assessment will be done on 14th day. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
01/07/2022 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
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 [anj3126@gmail.com].
- For how long will this data be available start date provided 17-01-2025 and end date provided 17-12-2025?
Response (Others) - One year post publication
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
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Brief Summary
|
Pratishyaya is one of the Urdvajatrugatavikara ,vata and kapha are said to be the predominant doshas.The symptoms of Rhinitis shows resemblance with the lakshana of Pratishyaya explained in Ayurveda classics.Pratishyaya is one of the disease in which the inflammation of mucous membrane of the nose is observed.It is characterised by Nasasrava(running nose), Nasavrodha(nasal blockage), Kshvathu(sneezing), Shirashoola(headache), Gandha ajana(loss of smell)etc. Rhinitis is the inflammation of the nasal mucous membrane. Rhinitis is the irritation and inflammation of the some internal areas of the nose. The inflammation results in the generation of excessive amount of mucous,commonly producing the runny nose as well as nasal congestion and post nasal drip.Rhinitis is caused by chronic and acute inflammation of mucous membrane of the nose due to viruses,bacteria,allergens. Rhinitis describes a group of symptoms including rhinorrhea,itching and sneezing that are caused by irritation and congestion in the nose.
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