| CTRI Number |
CTRI/2025/07/090475 [Registered on: 08/07/2025] Trial Registered Prospectively |
| Last Modified On: |
07/07/2025 |
| 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 effect of Yamanipanchak tablet 250 mg Twice a day for 5 days in loose motion in 6-12 yr children. |
|
Scientific Title of Study
|
Randomized open controlled clinical trial to evaluate the efficacy of Yamanipanchak vati in Balatisara W.S.R. Diarrhea 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 Snehal Laxman Gaikwad |
| Designation |
PG Scholar |
| Affiliation |
Yashwant Ayurvedic College PGT and RC Kodoli |
| Address |
OPD No.7 Kaumarbhritya Department Second floor Yashwant Ayurvedic College Post Graduate Training and Research Centre Kodoli Tal Panhala Dist Kolhapur Maharashtra India 416114
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
8349389487 |
| Fax |
|
| Email |
gaikwadsnehal75@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shailesh Raghunath Rajgolkar |
| Designation |
Associate Professor Kaumarbhritya Department PG Guide |
| Affiliation |
Yashwant Ayurvedic College PGT and RC Kodoli |
| Address |
OPD No.7 Kaumarbhritya Department Second floor Yashwant Ayurvedic College Post Graduate Training and Research Centre Kodoli Tal Panhala Dist Kolhapur Maharashtra India 416114
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
8308410222 |
| Fax |
|
| Email |
shaileshrajgolkar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Snehal Laxman Gaikwad |
| Designation |
PG Scholar |
| Affiliation |
Yashwant Ayurvedic College PGT and RC Kodoli |
| Address |
OPD No.7 Kaumarbhritya Department Second floor Yashwant Ayurvedic College Post Graduate Training and Research Centre Kodoli Tal Panhala Dist Kolhapur Maharashtra India 416114
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
8459389487 |
| Fax |
|
| Email |
gaikwadsnehal75@gamil.com |
|
|
Source of Monetary or Material Support
|
| Yashwant Ayurvedic College Post Graduate Training and Research Centre Kodoli Tal Panhala Dist Kolhapur Maharashtra India 416114 |
|
|
Primary Sponsor
|
| Name |
Dr. Snehal Laxman Gaikwad |
| Address |
OPD No.7 Kaumarbhritya Department Second floor Yashwant Ayurvedic College Post Graduate Training and Research Centre Kodoli Tal Panhala Dist Kolhapur Maharashtra India 416114 |
| 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 Snehal Laxman Gaikwad |
Yashwant ayurvedic College PGT and RC Kodoli |
OPD No.7 Kaumarbhritya Department Second floor Yashwant Ayurvedic College Post Graduate Training and Research Centre Kodoli Tal Panhala Dist Kolhapur Maharashtra India 416114
Kolhapur
MAHARASHTRA |
8459389487
gaikwadsnehal75@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Yashwant Ayurvedic College PGT and RC Kodoli Tal Panhala Dist Kolhapur Maharashtra India |
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 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Yamanipanchak Vati, Reference: ShriGovinda Das Sen vicharit Bhaishajyaratnavali, by Kaviraj Shri Ambikadatt Shashtri Ayurvedacharya, Chaukhmba prakashan, Varanasi, Balarogadhikar-Adhyay 71, Shlok 39, Page No. 1078, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 5 Days, anupAna/sahapAna: Yes(details: -Jal), Additional Information: -Dose according to age | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Syrup Balchaturbhadra, Reference: ShriGovinda Das Sen Vicharit Bhaishajyaratnavali, By Kaviraj Shri Ambikadatt Shashri Ayurvedacharya, Chaukhamba Prakashan, Varanasi, Balrogadhikar- Adhyay 71, Shlok 39, Page No. 1076, Route: Oral, Dosage Form: Sharkara/ Syrup, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 5 Days, anupAna/sahapAna: No, Additional Information: -Dose according to age |
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Age group 6 to 12 years irrespective of gender, irrespective of caste, socio-economic status, patients having Lakshnas of Balatisara like Malpravrutti, Udarashool, Aruchi, Daurbalya and Trushna. |
|
| ExclusionCriteria |
| Details |
Patients having age group below 6 years and above 12 years.
Known case of patient with chronic disorder.
Patient on any other long term medications.
Known case of patients suffering from any systemic disease which intervenes with treatment.
Patients having chronic and recurrent phases of Balatisara will be excluded.
Patient having Atisarah due to food poisoning.
Patient of infective diarrhea.
Symptoms of some and severe dehydration are excluded. |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the efficacy of Yamanipanchak vati in Balatisara with special reference to Diarrhea in children. |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To study the efficacy of Yamanipanchak vati in Balatisara by Ayurvedic and Modern point of view.
2. To assess improvement in signs and symptoms of Balatisara after treating by Yamanipanchak vati.
3. To study in detail, the causes, signs and symptoms of Balatisara.
4. To study in detail about Yamanipanchak vati.
5. To achieve the outcome of study in 7 days. |
7 days |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 3 |
|
Date of First Enrollment (India)
|
18/07/2025 |
| 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 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
|
Randomized open controlled clinical trial to evaluate the efficacy of Yamanipanchak vati in Balatisara W.S.R. to Diarrhea in children. The assessment of signs and symptoms will be done at regular follow up. Observation will be done from outcomes achieved in 7 days. |