CTRI

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CTRI Number

CTRI/2022/11/046968 [Registered on: 01/11/2022] Trial Registered Prospectively

Last Modified On:

20/10/2022

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug
Ayurveda
Preventive

Study Design

Randomized, Parallel Group Trial

Public Title of Study

To evaluate effect of Syrup Samangadi Yoga and Syrup Nagaradi Yoga in Atisar w.s.r. to Acute Diarrhoea in children.

Scientific Title of Study

A Comparative Clinical study to evaluate the efficacy of Syrup Samangadi Yoga and Syrup Nagaradi Yoga in Atisar w.s.r. to Acute Diarrhoea in children.

Trial Acronym

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Prof Rakesh Sharma
Designation	Prof and Head ,Department of Kaumarbhritya
Affiliation	RGGPG Ayu. College, Paprola,Teh.-Baijnath, Distt.-Kangra, H.P.
Address	Room No. 217,Anatomy block, RGGPG Ayurvedic College and Hospital Paprola, Kangra. Pandol Road,Teh.-Baijnath, Distt.-Kangra, H.P. ,PIN-176115 Kangra HIMACHAL PRADESH 176115 India
Phone	9418105049
Fax
Email	hodkbpaprola8@gmail.com

Details of Contact Person
Scientific Query

Name	Prof Rakesh Sharma
Designation	Prof and Head ,Department of Kaumarbhritya
Affiliation	RGGPG Ayu. College, Paprola,Teh.-Baijnath, Distt.-Kangra, H.P.
Address	Room No. 217,Anatomy block, RGGPG Ayurvedic College and Hospital Paprola, Kangra. Pandol Road,Teh.-Baijnath, Distt.-Kangra, H.P. ,PIN-176115 HIMACHAL PRADESH 176115 India
Phone	9418105049
Fax
Email	hodkbpaprola8@gmail.com

Details of Contact Person
Public Query

Name	Dr Kushal Sankhian
Designation	PG Scholar, Department of Kaumarbhritya
Affiliation	RGGPG Ayu. College, Paprola,Teh.-Baijnath, Distt.-Kangra, H.P.
Address	RGGPG Ayurvedic College and Hospital Paprola, Kangra Anatomy Block, RGGPG Ayurvedic College and Hospital Paprola, Kangra Kangra HIMACHAL PRADESH 176115 India
Phone	8283917906
Fax
Email	kushalsankhiankushal@gmail.com

Source of Monetary or Material Support

Charak Govt. Ayurvedic Pharmacy Paprola. Distt. Kangra, Herbal garden and herbarium, Research Institute in ISM, Jogindernagar, Distt. Mandi

Primary Sponsor

Name	RGGPG Ayurvedic College
Address	RGGPG Ayurvedic College and hospital Paprola, Kangra 176115
Type of Sponsor	Research institution and hospital

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Prof Rakesh Sharma	RGGPG Ayurvedic College Paprola	Room no-217, RGGPG Ayu. College, Paprola,Teh.-Baijnath, Distt.-Kangra, H.P. ,PIN-176115 Kangra HIMACHAL PRADESH	9418105049 hodkbpaprola8@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethical Committee	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition:K639\|\|Disease of intestine, unspecified. Ayurveda Condition: ATISARAH,

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Comparator Arm	Drug	Classical		(1) Medicine Name: Nagaradi Yoga, Reference: Chakradutt, Route: Oral, Dosage Form: Sharkara/ Syrup, Dose: 1(ml), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -0.5-1ml/kg body weight in three divided doses for 1 week
2	Intervention Arm	Drug	Classical		(1) Medicine Name: Samangadi Yoga, Reference: Chakradutt, Route: Oral, Dosage Form: Sharkara/ Syrup, Dose: 1(ml), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -0.5-1ml/kg body weight in three divided doses for 1 week

Inclusion Criteria

Age From	2.00 Year(s)
Age To	12.00 Year(s)
Gender	Both
Details	Children suffering from Atisar in between the age group of 2 to 12 years. Diarrhoea with or without mild dehydration. Patients who are willing to participate in the trial. Patients whose parents will give their written informed consent.

ExclusionCriteria

Details

Children Below 2 and above 12 year.
Persistent vomiting.
Patients suffering from Pravahika.
Patients suffering from Atisar as Upadrava in other diseases.
The patient who is suffering with any congenital, hereditary or acute systemic illness

Method of Generating Random Sequence

Random Number Table

Method of Concealment

Alternation

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
Fulfillment of Objective and Subjective Criteria	1 Week

Secondary Outcome

Outcome	TimePoints
Control of Diarrhoeal episodes	7 Days

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

Phase 2

Date of First Enrollment (India)

10/11/2022

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 Yet Recruiting

Recruitment Status of Trial (India)

Not Yet Recruiting

Publication Details

Not yet

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary

I would like to publish my research trial after completion as soon as possible . A total 40 subjects will be studied in two groups. 20 Patients will be given Syrup Samangadi Yoga and 20 Patients will be given Syrup Nagaradi Yoga. The outcome will be analysed based on subjective and objective parameters with appropriate statistical tools.