| CTRI Number |
CTRI/2023/07/055763 [Registered on: 27/07/2023] Trial Registered Prospectively |
| Last Modified On: |
26/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A randomized controlled clinical trial to evaluate the efficacy of Ajamoda Arka in Udarshool in Ksheerapavastha. |
|
Scientific Title of Study
|
A RANDOMIZED CONTROLLED CLINICAL TRIAL TO EVALUATE THE EFFICACY OF AJAMODA ARKA IN UDARSHOOL IN KSHEERAPAVASTHA. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR SURABHI ARUN YADGIRE |
| Designation |
P.G. SCHOLAR Pre M.D. |
| Affiliation |
YASHWANT AYURVEDIC COLLEGE POST GRADUATE TRAINING AND RESEARCH CENTRE |
| Address |
Opd no 7, Kaumarbhritya opd. Yashwant Ayurvedic Hospital ,Kodoli
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
7030449657 |
| Fax |
|
| Email |
surabhiyadgire@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pravatkumar Dash |
| Designation |
Professor HOD |
| Affiliation |
YASHWANT AYURVEDIC COLLEGE POST GRADUATE TRAINING AND RESEARCH CENTRE |
| Address |
Opd no 7, Kaumarbhritya opd. Yashwant Ayurvedic Hospital ,Kodoli
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9423277590 |
| Fax |
|
| Email |
drpkdash25@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SURABHI ARUN YADGIRE |
| Designation |
P.G. SCHOLAR Pre M.D. |
| Affiliation |
YASHWANT AYURVEDIC COLLEGE POST GRADUATE TRAINING AND RESEARCH CENTRE |
| Address |
Opd no 7, Kaumarbhritya opd. Yashwant Ayurvedic Hospital ,Kodoli
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
7030449657 |
| Fax |
|
| Email |
surabhiyadgire@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yashwant Ayurvedic College Kodoli. |
|
|
Primary Sponsor
|
| Name |
Dr Surabhi Arun Yadgire |
| Address |
Yashwant Ayurvedic medical College kodoli, kolhapur, Maharashtra |
| 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 Surabhi Arun Yadgire |
Yashwant Ayurvedic College |
Opd no 7, Kaumarbhritya Department, Yashwant Ayurvedic College, Kodoli, Kolhapur
Kolhapur
MAHARASHTRA |
7030449657
surabhiyadgire@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K929||Disease of digestive system, unspecified. Ayurveda Condition: ADHMANAM, (2) ICD-10 Condition:K00-K95||Diseases of the digestive system. Ayurveda Condition: Udarshool(उदरशूल), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Avartani Arka, Reference: Priya Nighantu, Route: Oral, Dosage Form: Arka, Dose: 0.16(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 5 Days, anupAna/sahapAna: No, Additional Information: 0.16ml/kg Avartani Arka will be given to control group. | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Ajamoda, Reference: Dhanwantari Nighantu, Route: Oral, Dosage Form: Arka, Dose: 0.16(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 5 Days, anupAna/sahapAna: No, Additional Information: 0.16ml/kg/day |
|
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
6.00 Month(s) |
| Gender |
Both |
| Details |
1)Children of Ksheerapavastha i.e. 0-1 years irrespective of Gender.
2) Patients having at least any two of the following symptoms of udarshool, like excessive cry, refusal to feed, irritability, abdominal distension or tenderness, etc. As mentioned in Ayurveda classics (Kaashyap samhita) and according to modern textbooks.
3) Patients having history of crying for more than 3 hrs/day, for more than 3 days in week, for at least 1 week. OR patients having history of at least any two of the following symptoms of udarshool, like excessive cry, refusal to feed, irritability, abdominal distension or tenderness, etc. |
|
| ExclusionCriteria |
| Details |
1) Udarshool associated with fever, vomiting, diarrhoea, constipation, acute infectious diseases like Gastro intestinal tract infections, urinary tract infections etc.
2) Known case of congenital anomalies.
3) Patient having food allergies like lactose intolerance, IEM etc.
4) Failure to thrive. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare efficacy of Shunthi Arka with Avartani Arka 0.16ml/kg/day Vyanodane in Udarshool in Ksheerapavastha for 5 days. |
To compare efficacy of Shunthi Arka with Avartani Arka 0.16ml/kg/day Vyanodane in Udarshool in Ksheerapavastha for 5 days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the adverse effect of Shunthi Arka if any. |
5 days |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
07/08/2023 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 study is randomised controlled clinical trail study to evaluate the efficacy of Ajamoda Arka in Udarshool in Ksheerapavstha. Study will be carried in Kaumarbhritya OPD of Yashwant ayurvedic College and Hospital kodoli . The observation would be drawn on the basis of signs after treatment given . |