| CTRI Number |
CTRI/2025/09/094136 [Registered on: 02/09/2025] Trial Registered Prospectively |
| Last Modified On: |
02/09/2025 |
| 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
|
Study of the effect of Bilvadi Churna (Granules) in comparision to Kutaj Ghanvati in Atisara in children |
|
Scientific Title of Study
|
Comparative clinical evaluation of Bilvadi Churna (Granules) and Kutaj Ghanvati in Atisara 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 |
Akash Ramesh Burud |
| Designation |
PG Scholar |
| Affiliation |
Gurukul Campus Uttarakhand Ayurved University, Haridwar |
| Address |
OPD 9 Department of Kaumarbhritya Gurukul Campus Uttarakhand Ayurved University Haridwar Uttarakhand
Hardwar
UTTARANCHAL
249404
India |
| Phone |
7030710396 |
| Fax |
|
| Email |
akashburud12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr GP Garg |
| Designation |
Professor and HOD Department of Kaumarbhritya |
| Affiliation |
Gurukul Campus Uttarakhand Ayurved University, Haridwar |
| Address |
OPD 9 Department of Kaumarbhritya Gurukul Campus Uttarakhand Ayurved University Haridwar Uttarakhand
Hardwar
UTTARANCHAL
249404
India |
| Phone |
6395611281 |
| Fax |
|
| Email |
drgarggp@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr GP Garg |
| Designation |
Professor and HOD Department of Kaumarbhritya |
| Affiliation |
Gurukul Campus Uttarakhand Ayurved University, Haridwar |
| Address |
OPD 9 Department of Kaumarbhritya Gurukul Campus Uttarakhand Ayurved University Haridwar Uttarakhand
Hardwar
UTTARANCHAL
249404
India |
| Phone |
6395611281 |
| Fax |
|
| Email |
drgarggp@gmail.com |
|
|
Source of Monetary or Material Support
|
| Uttarakhand Ayurveda University Gurukul Campus Haridwar Uttarakhand India Pin code 249404 |
|
|
Primary Sponsor
|
| Name |
Akash Ramesh Burud |
| Address |
OPD No 9 Department of Kaumarbhritya Uttarakhand Ayurved University Gurukul Campus Haridwar |
| 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 Akash Ramesh Burud |
Uttarakhand Ayurved University Gurukul Campus Haridwar |
OPD 9 PG Department of Kaumarbhritya Gurukul Campus Uttarakhand Ayurved University Haridwar Uttarakhand
Hardwar
UTTARANCHAL |
7030710396
akashburud12@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Gurukul Campus |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K928||Other specified diseases of the digestive system. Ayurveda Condition: ATISARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Kutaj Ghanvati, Reference: Siddha Yoga Sangraha, Author - Vaidya Yadavji Trikamaji Acharya, Chapter 2 - Atisara Pravahika Grahnyadhikara, Page No. 26, Kutaj - Bhavaprakash, Guduchyadi varga, Shloka No. 118, Ativisha- Bhavaprakash, Haritkyadi varga, Shloka No. 214, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 125(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: Boiled water at room temperature), Additional Information: 5-10 years - 125mg TDS 10-16 years- 250mg TDS | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Bilvadi Churna (Granules), Reference: Chakradath Samhita, Vyakhyakar Dr Indradev Tripathi, Chapter No. 64 Balroga Chikitsa, Shloka No. 31, Page No. 396, Route: Oral, Dosage Form: Khanda /Granules, Dose: 5(g), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: Boiled water at room temperature), Additional Information: 5-10 years- 5gm TDS 10-16 years- 10gm TDS |
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
1. Case of Atisara as per classical symptoms: Muhura Muhura Mala Pravritti (Increased
Frequency of stool),Udara Shoola (Abdominal pain), Atidrava Mala Pravritti (Loose
Consistency of stool), Agnimandya (Decreased appetite), Durgandhit Mala (Foul smell)
2. Patient suffering from Acute diarrhoea (with history upto 7 days) |
|
| ExclusionCriteria |
| Details |
1. Children below age of 5 years and above 16 years.
2. Severe diarrhoea.
3. Persistent vomiting.
4. Bloody stools.
5. Moderate and severe dehydration.
6. Known case of worm infestation induced diarrhoea.
7. Patient suffering from any other Systemic disorder, Congenital anomalies,
Immune deficiency disorder and Inborn errors of metabolism. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Muhura Muhura Mala Pravritti (Increased
Frequency of stool)
Udara Shoola (Abdominal pain)
Atidrava Mala Pravritti (Loose
Consistency of stool)
Agnimandya (Decreased appetite)
Durgandhit Mala (Foul smell) |
The assessment of patient will be done at 1st day, 4th day and 7th day and follow-up (post treatment) will done after 3rd day of the cessation of medicine. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Complete cure from all classical symptoms of Atisara |
The assessment of patient will be done at 1st day, 4th day and 7th day and follow-up (post treatment) will done after 3rd day of the cessation of medicine. |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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 |
|
Date of First Enrollment (India)
|
10/10/2025 |
| 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 study is a Comparative clinical evaluation of Bilvadi Churna (Granules) and Kutaj Ghanvati in Atisara in children for the age group of 5 to 16 years for 7 days. Study will be conducted at UAU, Gurukul Campus, Haridwar on 34 patients. Assessment will be done on the basis of subjective and objective parameters. Study will be conducted at OPD/IPD level of PG department of Kaumarbhritya. The Assessment will be done at 1st day, 4th day and 7th day and follow-up (post treatment) will be done after the 3rd day of the cessation of medicine (10th day) and result obtained will be tabulated and statistically analyzed using appropriate tests. |