| CTRI Number |
CTRI/2022/06/043408 [Registered on: 21/06/2022] Trial Registered Prospectively |
| Last Modified On: |
27/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical Study on the Efficacy of
Fluticasone Vs Bharangi Arka Nasal Spray in
Pratishyaya (Chronic Allergic Rhinitis) in Children. |
|
Scientific Title of Study
|
Randomized Controlled clinical Study on the Efficacy of
Fluticasone and Bharangi(Clerodendrom serratum Linn) Arka as a Nasal Spray in
Pratishyaya (Chronic Allergic 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 |
DrDeepthi Balakrishnan |
| Designation |
Professor |
| Affiliation |
PNNM Ayurveda Medical College |
| Address |
PNNM Ayurveda Medical College
Department of kaumarabrithya
Cheruthuruthy P.O
Thrissur
Kerala
Cheruthuruthy P.O
Thrissur
Kerala
Thrissur
KERALA
679531
India |
| Phone |
8547514940 |
| Fax |
|
| Email |
drdeepthimanu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrDeepthi Balakrishnan |
| Designation |
Professor |
| Affiliation |
PNNM Ayurveda Medical College |
| Address |
PNNM Ayurveda Medical College
Department of Kaumarabrithya
Cheruthuruthy P.O
Thrissur
Kerala
Cheruthuruthy P.O
Thrissur
Kerala
Thrissur
KERALA
679531
India |
| Phone |
8547514940 |
| Fax |
|
| Email |
drdeepthimanu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrDeepthi Balakrishnan |
| Designation |
Professor |
| Affiliation |
PNNM Ayurveda Medical College |
| Address |
PNNM Ayurveda Medical College
Department of Kaumarabrithya
Cheruthuruthy P.O
Thrissur
Kerala
Cheruthuruthy P.O
Thrissur
Kerala
Thrissur
KERALA
679531
India |
| Phone |
8547514940 |
| Fax |
|
| Email |
drdeepthimanu@gmail.com |
|
|
Source of Monetary or Material Support
|
| MAHATMA GANDHI AYURVED COLLEGE, HOSPITAL & RESEARCH CENTRE,
SALOD(H),
WARDHA,
MAHARASHTRA. |
|
|
Primary Sponsor
|
| Name |
DrDeepthi Balakrishnan |
| Address |
Mrinal (H)
Chungam
Cheruthuruthy P.O
Thrissur |
| 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 Renu Rathi |
MAHATMA GANDHI AYURVED COLLEGE, HOSPITAL & RESEARCH CENTRE |
Department of Kaumarabrithya
SALOD(H), WARDHA
Wardha
MAHARASHTRA |
9373703816
rbr.226@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MAHATMA GANDHI AYURVED COLLEGE, HOSPITAL & RESEARCH CENTRE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J310||Chronic rhinitis. Ayurveda Condition: PRATISYAYAH/PINASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Bharangi Arka, Reference: Arka Prakash, Route: Nasal, Dosage Form: Arka, Dose: 0.26(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 1 Months, anupAna/sahapAna: No, Additional Information: -As a Nasal Spray | | 2 | Comparator Arm (Non Ayurveda) | | - | Fluticasone | (1) Medicine Name: Fluticasone, Route: nasal, Dosage Form: Liquid spray, Dose: 200mcg, Frequency: Bd, Duration: 1 month, Additional Information:- as a Nasal Spray |
|
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients irrespective of gender, religion, and socioeconomic status.
2 Patients with Pratishyaya for more than 1 week or recurrent 3-6 episodes in a year
(Chronic Allergic Rhinitis).
3 Parents who are ready to provide written informed consent to their children. |
|
| ExclusionCriteria |
| Details |
1 Patients with Acute Allergic Rhinitis.
2 DushtaPratishyaya, RakthaPratishyaya and
SannipatajaPratishyaya.
3 Infectious diseases like T.B.
4 Patients suffering from Cleft Palate, DNS, and
Nasal Polyps
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Rhinorrhea and Sneezing expected to decrease after treatment from 1st day to the 7th day |
1st day
7th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Kasam,Shirashoola,Aruchi,Nasal Itching and Nasal Obstruction expected to decrease after treatment from 8th to 28th |
8th day
28th day |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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)
|
15/11/2022 |
| 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="4"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Autism spectrum disorder (ASD) is a complex developmental condition characterized by qualitative abnormalities in social interactions, reduced communication skills, and restricted repetitive behaviors and activities. There is no direct reference to ASD in Samhitas and it can be considered as an Anukta vyadhi. Unmada, a disease that afflicts manovaha srothas, is characterized by the perversion of intellect, mind, and memory.ASD can be correlated to Vatika unmada. The treatment of unmada involves various Ayurvedic formulations. Medha gulika is a polyherbal formulation indicated in anxiety and mental depression, dementia and it improves memory, concentration, and brain functioning (medhya). Bhunaga Talia is an anubhootayoga indicated in treatment of apasmara, bhootonmada, vaksanga etc.Nasya and shiroshirodhara are effective in treating manovaha srothovikaras. Bhunaga taila and Medha gulika can be combined to develop an effective treatment protocol for ASD. The main aim of this study is to develop a protocol of treatment for a patient suffering from ASD, which helps manage the symptoms and make behavioral improvement. A 5-year-old female child who was brought to the OPD with the diagnosis of ASD was treated with both these medicines and the changes before and after the treatment was noted based on the Trivandrum Autism Behavioral Checklist (TABC). Minimal improvement was noted in the behavior of the child following treatment of 90 days. |