| CTRI Number |
CTRI/2024/07/071594 [Registered on: 30/07/2024] Trial Registered Prospectively |
| Last Modified On: |
30/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Curative] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study to evaluate the effect of polyherbal decoction in childhood urticaria |
|
Scientific Title of Study
|
A Randomized Comparative Clinical Study To Evaluate The Efficacy Of Amrutharajanyadi Kashaya And Standard Care In Childhood Urticaria |
| 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 Pradeep N |
| Designation |
PG Scholar |
| Affiliation |
JSS Ayurveda Medical College And Hospital |
| Address |
JSS Ayurveda College And Hospital
Kaumarabrithya OPD room no 11
41/E Lalithadripura Road Alanahalli Mysuru 570028
Mysore
KARNATAKA
570028
India |
| Phone |
9739559183 |
| Fax |
|
| Email |
builderpradee@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Srihari S |
| Designation |
Professor And Head Of The Department |
| Affiliation |
JSS Ayurveda Medical College And Hospital |
| Address |
JSS Ayurveda College And Hospital
Kaumarabrithya OPD room no 11
41/E Lalithadripura Road Alanahalli Mysuru 570028
Mysore
KARNATAKA
570028
India |
| Phone |
7776077626 |
| Fax |
|
| Email |
Dr.srihari@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pradeep N |
| Designation |
PG Scholar |
| Affiliation |
JSS Ayurveda Medical College And Hospital |
| Address |
JSS Ayurveda College And Hospital
Kaumarabrithya OPD room no 11
41/E Lalithadripura Road Alanahalli Mysuru 570028
Mysore
KARNATAKA
570028
India |
| Phone |
9739559183 |
| Fax |
|
| Email |
builderpradee@gmail.com |
|
|
Source of Monetary or Material Support
|
| Raw drugs will be collected from the local market after proper
identification and authentication by the Department of Dravyaguna, JSSAMC
Mysore. Medicine required for the procedure will be prepared in Rasa Shastra and
Bhaishajya Kalpana laboratory, a G.M.P. certified unit, Mysore. |
|
|
Primary Sponsor
|
| Name |
Dr Pradeep N |
| Address |
JSS Ayurveda Medical college and hospital
41/E, Lalithadripura Road Alanhalli Mysuru 570028
India |
| Type of Sponsor |
Other [Dr Pradeep N ] |
|
|
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 |
| Pradeep N |
JSS Ayurveda medical college |
Kaumarabrithya OPD room no 11
41e lalitadripura road alanahalli mysuru
Mysore
KARNATAKA |
9739559183
builderpradee@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Clearance Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L509||Urticaria, unspecified. Ayurveda Condition: SITAPITTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Amrutharajanyadi kashaya, Reference: sahasrayogam, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 15(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: sita), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | STANDARD | Levocetrizine
2–5 years—1.25 mg OD, 6–11 years—2.5 mg OD,
>12 years—5 mg OD
For 28 days |
|
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
1) Children aged between 4 to 16 years of irrespective of gender, socioeconomic status.
2) Children showing classical clinical features of Sheetapitta and Udarda with mild
fever (99.5F-100.5F)
3) Children showing features of Urticaria and dermographism. |
|
| ExclusionCriteria |
| Details |
1)Known case of any systemic disorders which interfere with the course of study.
2) Known history of anaphylaxis to any medicine.
3) Known history of severe cases of angioedema.
4) Other skin conditions with similar presentations like wasp bite.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To study the effect of Amrutharajanyadi Kashaya on the clinical features,
number of reduction of episodes, time taken for reduction of rashes and the values of TC, DC, AEC and IGE
|
Baseline
15th and 28th day
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate & compare the effect of Amrutharajanyadi Kashaya & standard care
on quality-of-life parameters in children suffering from Urticaria |
Baseline
15th 28th |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
20/08/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/08/2024 |
| 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
|
Urticaria is a dermal vascular reaction of the skin characterized by the appearance of itchy
wheals, which are elevated (oedematous), pale or erythematous, transient and evanescent plaque
lesions. The clinical picture of urticaria closely resemble with that of Sheetapitta described in Ayurveda
classics. Sheetapitta is characterized by skin lesions which resembles Varathidamshta samsthana shotha
(Appearance of swelling resembling as that of bite of wasp), Kandu(itching), Bahula Thoda
(excessive pricking pain), Vidaha (burning sensation) associated with chardi (vomitting) and
jwara(fever). Vata is predominant dosha in Sheetapitta. Although many cases of urticaria are self limiting, in case of chronic and recurrent conditions,
parents generally sought treatment. To combat the hypersensitivity reaction in the body,
administration of immunomodulatory drugs will be helpful especially in children who are
having under developed immunity.
The selected trial drug, Amrutha Rajanyadi Kashaya
contains drugs having proven immunomodulatory activity which will be helpful in managing the
condition in children effectively. The primary objectives of the study are to study the effect of Amrutharajanyadi Kashaya and standard care in the management of childhood
Urticaria separately and to to compare the effect in both the groups. The secondary objective is to evaluate and compare the effect of Amrutharajanyadi Kashaya and standard care
on quality-of-life parameters in children suffering from Urticaria. The study hypothesize that Amrutharajanyadi Kashaya is as effective as standard care in managing childhood urticaria. |