| CTRI Number |
CTRI/2025/01/079314 [Registered on: 23/01/2025] Trial Registered Prospectively |
| Last Modified On: |
22/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the efficacy of Lodhradi Churna with Balchaturbhadra Churna in the management of Pittaj Atisara in children of age group 1 to 5 years |
|
Scientific Title of Study
|
Comparative Clinical Study to evaluate the efficacy of Lodhradi Churna with Balchaturbhadra Churna in the management of Pittaj Atisara in children of age group 1 to 5 Years. |
| 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 Vivek Gitaram Chothe |
| Designation |
MD Scholar Kaumarbhritya |
| Affiliation |
MAM S Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune 411028 |
| Address |
MAM S Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune OPD no 13 Department of Kaumarbhritya Sane Guruji Arogya Kendra Malwadi Hadapsar Pune
MAM S Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar pune OPD no 13 Sane Guruji Arogya Kendra Malwadi Hadapsar Pune 411028
Pune
MAHARASHTRA
411028
India |
| Phone |
8380833458 |
| Fax |
|
| Email |
vivekgchothe@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ramchandra Babar |
| Designation |
Professor of Department of Kaumarbhritya |
| Affiliation |
MAM S Sumatibhai Shah Ayurved Mahavidyalaya Sane Guruji Arogya Kendra |
| Address |
MAM S Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar OPD no 13 Department of Kaumarbhritya Sane Guruji Arogya Kendra Malwadi Hadapsar Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
8275459236 |
| Fax |
|
| Email |
ramchandrababar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vivek Gitaram Chothe |
| Designation |
MD Scholar Kaumarbhritya |
| Affiliation |
MAM S Sumatibhai Shah Ayurved Mahavidyalaya Sane Guruji Arogya Kendra Malwadi Hadapsar Pune |
| Address |
MAM S Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune OPD no 13 Sane Guruji Arogya Kendra Malwadi Hadapsar Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
8380833458 |
| Fax |
|
| Email |
vivekgchothe@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Kaumarbhritya, Sane Guruji Arogya Kendra, Malwadi, Hadapsar Pune Maharashtra India 411028 |
|
|
Primary Sponsor
|
| Name |
Sane Guruji Arogya Kendra |
| Address |
Sane Guruji Arogya Kendra Malwadi Hadapsar Pune Maharashtra India 411028 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Vivek Gitaram Chothe |
Sane Guruji Arogya Kendra |
OPD no 13 Department Of Kaumarbhritya Sane Guruji Arogya Kendra Malwadi Hadapsar Pune
Pune
MAHARASHTRA |
8380833458
vivekgchothe@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, MAMs Sumatibhai Shah Ayurved Mahavidyalaya and Sane Guruji Arogya Kendra |
Approved |
|
|
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: ATISARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Balchaturbhadra Churna, Reference: Bhaishajya ratnavali, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: Madhu), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Lodhradi Churna, Reference: Yogratnakar Balchikitsa, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: Madhu), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
The study will select patients of age group 1 to 5 years, regardless of gender, socioeconomic status, or food habits. Eligible patients will exhibit at least classical symptoms of Pittaj Atisara, including Harit, Pita, Asita Malpravrutti, Trushna, Dahaa, Murchha, Udarsool, Jwara, Durgandhit Mala, and Sweda.
Additionally, patients with more than three episodes of loose motions in 24 hours, acute diarrhea with mild dehydration, and whose parents or guardians provide written consent and assent for participation in the clinical trial will be included. |
|
| ExclusionCriteria |
| Details |
Patients having any chronic or systemic illness.
Patients of moderate to severe dehydration.
Patients suffering from Pravahika, Visuchika and Rakta atisara.
Patients suffering from chronic diarrhoea, persistent diarrhoea or diarrhoea due to congenital or acquired immunodeficiency.
Patients having major problems which require surgical corrections like intussusception and any other.
Patients with malabsorption syndrome.
Patients having diarrhoea due to lactose intolerence. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate efficacy of lodhradi churna and balchaturbhadra Churna in the management of pittaj atisara in children of age group 1 to 5 years. |
Treatment will be given for 7 days.
Lodhradi churna will be given for one group and balchaturbhadra Churna will be given for another group.
Follow up and assessment will be done on 3rd, 5th and 7th day.
Final observation will be recorded after completion of treatment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Literature study of pittaj atisara in paediatric age
group.
To observe adverse effect if any. |
Study will be done using Ayurvedic Granthas & modern texts.
Preparation of drug will be done according to the standard procedure.
During the treatment observation will be done on 3rd, 5th & 7th day & later adverse effect. |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
05/02/2025 |
| 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="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 comparative clinical study aims to assess the efficacy of Lodhradi Churna with Balchaturbhadra Churna in managing Pittaj Atisara in children of age group 1 to five years. The study will consists of two trial groups, each with 40 patients, who will receive either Lodhradi Churna or Balchaturbhadra Churna along with Madhu for 7 days according to predefined assessment criteria. Simple random sampling will be used to assign patients to each group and dosing will be determined based on patients age according to Dilling formula.
|