| CTRI Number |
CTRI/2024/08/072709 [Registered on: 19/08/2024] Trial Registered Prospectively |
| Last Modified On: |
12/07/2024 |
| 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
|
To evaluate the efficacy of Sariva malahara in Ahiputana in children,A Randomized controlled clinical trial |
|
Scientific Title of Study
|
“A RANDOMIZED CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFICACY OF SARIVA MALAHARA IN AHIPUTANA IN CHILDREN†|
| 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 Ashwini S Tavarakhed |
| Designation |
PG scholar |
| Affiliation |
Alvas Ayurveda medical college and Hospital |
| Address |
Alvas Ayurveda medical college Moodubidire, Dakshina kannada,
Alvas Ayurveda medical college Moodubidire, Dakshina kannada 574227
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
7349162679 |
| Fax |
|
| Email |
ashwinitawarakhed@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashwini S Tavarakhed |
| Designation |
PG scholar |
| Affiliation |
Alvas Ayurveda medical college |
| Address |
Alvas Ayurveda medical college and hospital Moodubidire, Dakshina kannada, 574227
Alvas Ayurveda medical college and hospital Moodubidire, Dakshina kannada,574227
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
7349162679 |
| Fax |
|
| Email |
ashwinitawarakhed@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr NARAYAN PAI B |
| Designation |
PROFESSOR DEPT. OF P.G. STUDIES IN KAUMARABHRITYA |
| Affiliation |
Alvas Ayurveda medical college Moodubidire |
| Address |
Alvas Ayurveda medical college Moodubidire,Dakshina, karnataka, 574227
Alvas Ayurveda medical college Moodubidire,Dakshina, karnataka, 574227
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9902329719 |
| Fax |
|
| Email |
drnarayanpai@gmail.com |
|
|
Source of Monetary or Material Support
|
| Alvas Ayurveda medical college Moodubidire |
|
|
Primary Sponsor
|
| Name |
Dr Ashwini S Tavarakhed |
| Address |
Alvas Ayurveda medical college Moodubidire, Dakshina kannada, karnataka 574227 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| DrAshwini S Tavarakhed |
Alvas Ayurveda Medical College and Hospital, Moodubidire, Dakshina Kannada, Karnataka |
Alvas Ayurveda Medical
College and Hospital,
Moodubidire, Dakshina
Kannada, Karnataka
Dakshina Kannada
KARNATAKA |
7349162679
ashwinitawarakhed@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE ALVAS AYURVEDA MEDICAL COLLEGE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L089||Local infection of the skin and subcutaneous tissue, unspecified. Ayurveda Condition: AHIPUTANA/AHIPUTANAKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Sariva malahara, Reference: Ashtanga sangraha,Uttara tantra 2nd chapter,Balamayaprathisheda Adhyaya, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 2(NA), Frequency: bd, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 7 Days, Reference: No, Route: -, Dosage Form: Malahara/ Ointment/ Balm, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Day(s) |
| Age To |
2.00 Year(s) |
| Gender |
Both |
| Details |
1.Children with 2 or more symptoms among the diagnosing criteria will be selected for the study.
2.Children in between the age group 3rd week to till 2 years, irrespective of gender, religion, socioeconomic status.
3.H/o of symptoms of Ahiputana / Napkin rash not more than 10 days.
|
|
| ExclusionCriteria |
| Details |
1.Children suffering from any other systemic disorders e.g, Acute gastro enteritis with dehydration, helminthic infection, lactogen intolerance, secondary infection etc.
2.Children who have other generalized skin infections other than Ahiputana.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
assessment will be done based on subjective and objective parameters by grading them.
Subjective
a.Kandu(Itching)
b. Ruja(Irritability)
Objective
a.Vivarnata (Erythema)
b. Distribution of rash (W shape distribution of rash at genitocrural folds)
c. Pidaka (papulo-vesicular rash)
d. Srava (discharge)
|
14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assesse the mode of action of Sariva malahara in Ahiputana in childrens |
14 days |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/11/2024 |
| 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="15" |
|
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
|
This is randomize controlled clinical study, with intervention of sariva malahara in Ahiputana in children age group between 21days or 3 weeks to 2 years comparison with the daruharidra malahara. Study will be conducting in Alvas Ayurveda Medical College And Hospital, Vidyagiri, Moodabidri. Interventional period of this study is 14 days assessment will be done on before treatment, 3rd day,5th day and 7th day, Follow up on 10th and 14 th day |