| CTRI Number |
CTRI/2024/07/070107 [Registered on: 05/07/2024] Trial Registered Prospectively |
| Last Modified On: |
03/07/2024 |
| 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
|
Efficacy of Ajamoda Arka with Yava Kshara in the Management of Vataja Udarashoola, Infantile Colic in infants with the age group 1 to 5 months for the duration of 15 days
|
|
Scientific Title of Study
|
Efficacy of Ajamoda Arka with Yava Kshara in the Management of Vataja Udarashoola, Infantile Colic
|
| 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 Tale Vaibhav Vitthalrao |
| Designation |
PG Scholar |
| Affiliation |
Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Bangalore |
| Address |
Department of Kaumarbhritya OPD No.7,8,9,22,23
Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, SH17, Anchepalya, Challegatta, Bangalore 560074,Karnataka, India
Bangalore
KARNATAKA
560074
India |
| Phone |
8310927937 |
| Fax |
|
| Email |
drvaibhavtale@sdmayurbangalore.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Reena K |
| Designation |
Professor |
| Affiliation |
Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Bangalore |
| Address |
Department of Kaumarbhritya OPD No.8
Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, SH17, Anchepalya, Challegatta, Bangalore 560074,Karnataka, India
Bangalore
KARNATAKA
560074
India |
| Phone |
9480478639 |
| Fax |
|
| Email |
drreenakulkarni@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tale Vaibhav Vitthalrao |
| Designation |
PG Scholar |
| Affiliation |
Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Bangalore |
| Address |
Department of Kaumarbhritya OPD No.7,8,9,22,23
Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, SH17, Anchepalya, Challegatta, Bangalore 560074,Karnataka, India
Bangalore
KARNATAKA
560074
India |
| Phone |
8310927937 |
| Fax |
|
| Email |
drvaibhavtale@sdmayurbangalore.in |
|
|
Source of Monetary or Material Support
|
| Department of Kaumarbhritya OPD No.7,8,9,22,23
Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, SH17, Anchepalya, Challegatta, Bangalore 560074,Karnataka, India. |
|
|
Primary Sponsor
|
| Name |
Dr Tale Vaibhav Vitthalrao |
| Address |
Department of Kaumarbhritya OPD No.7,8,9,22,23
Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, SH17, Anchepalya, Challegatta, Bangalore 560074,Karnataka, India. |
| 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 Tale Vaibhav Vitthalrao |
Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Bangalore |
Department of Kaumarbhritya OPD No.7,8,9,22,23
Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, SH17, Anchepalya, Challegatta, Bangalore 560074,Karnataka, India.
Bangalore
KARNATAKA |
8310927937
drvaibhavtale@sdmayurbangalore.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Bangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:R108||Other abdominal pain. Ayurveda Condition: SULAH, , |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: shatapushpa arka, Reference: Arka Prakash Tritiya satkam, Route: Oral, Dosage Form: Arka, Dose: 1(ml), Frequency: tds, Bhaishajya Kal: Abhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Ajamoda arka, Reference: Arogya Raksha Kalpdrum chapter vriddhi gulma udara shula chikitsa adhyaya., Route: Oral, Dosage Form: Arka, Dose: 1(ml), Frequency: tds, Bhaishajya Kal: Abhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -takra), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
5.00 Month(s) |
| Gender |
Both |
| Details |
1.Infants of either gender diagnosed with infantile colic as per ROME IV criteria
2.Infants aged 1 month to 5 months
3.Infants with recurrent and prolonged periods of crying, fussiness or irritability as reported by care givers that occur without any apparent cause and cannot be prevented or consoled by care givers
4.Full term healthy neonates
5.Mothers and care givers who are willing to participate and ready to give written consent
|
|
| ExclusionCriteria |
| Details |
1.Infants with disorder of bowel or urinary tract disorders that might present as abdominal distension, inguinal swelling or scrotal swelling.
2.Infants with chronic or acute systemic illnesses of gastrointestinal, Respiratory etc.
3.Infants with known cases of chromosomal, metabolic and hereditary Disorders.
4.Infants or their who are on medication or diet that may interfere with study objectives.
5.Breast feeding mothers or their kids on antibiotic therapy in the last 15 days.
6.Mothers who consume alcohol, smoke and tobacco.
7.Infants who are on formula feed or animal(feed) milk.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)Reduction in the clinical features of Vataja udara shoola.
2)Reduction in the Intensity of cry & fussing by FUSSINESS rating scale.
|
Baseline, 15 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Decrease in Pain, improvement in activity and sleep behaviour based on FLACC scale.
2) Improvement in the Gastro intestinal features- IGSQ score.
|
Baseline, 15 Days |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
15/07/2024 |
| Date of Study Completion (India) |
20/05/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
A open labelled randomized controlled
clinical trial on the efficacy of Ajamoda arka with Yava kshara in the
management of Vataja Udarshoola, Infantile colic in infants of age
group 1 to 5 months.during this study period, 50 childrens will be recruited
and divided into 2 groups, Group A(trial group) and Group B(control group),25
in each group. Group A(trial group) infants will be adminstered ajamoda arka
with yavakshara (for the age of 1 to 3 month 0.5 ml TID with 1 ml
takra(anupana) and for the age of 4 to 5 months 1ml TID with 2ml anupana
takra)and Group B (Control group) infants will be adminstered shatapushpa arka (for
the age of 1 to 3 months,0.5ml TID and for 4 to 5 months 1ml TID) for a period
of 15 days. Clinical assesement will be done for both subjective and objective
criteria on 0th day, 7th day and 16th day.
Follow up on 21st day. Statistical anylysis will be done through
data collected on 0th day and 16th day.
|