| CTRI Number |
CTRI/2021/08/035634 [Registered on: 13/08/2021] Trial Registered Prospectively |
| Last Modified On: |
12/08/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Efficacy of Sanjeevani Vati in Infective Diarrhoea |
|
Scientific Title of Study
|
A study on Sanjeevani Vati with special reference to Pharmaceutico-Analytical,In Vitro Anti Microbial effect on common Diarrhoeal pathogens and its clinical evaluation as empirical therapy in Infective Diarrhoea |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrManik Soni |
| Designation |
Lecturer, Kayachikitsa Department (Room No.207) |
| Affiliation |
RGGPG Ayurvedic College and Hospital Paprola |
| Address |
RGGPG Ayurvedic and Paprola Distt.Kangra H.P. (176115)
RGGPG Ayurvedic and Paprola Distt.Kangra H.P. (176115)
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
8219121014 |
| Fax |
|
| Email |
drmsony@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sudershan k Thakur |
| Designation |
Professor, Ras Shastra & Bhaishjya kalpana deptt. |
| Affiliation |
|
| Address |
Doon Institute of Medical Sciences,Sahaspur,Dehradun
Doon Institute of Medical Sciences,Sahaspur,Dehradun
Dehradun
UTTARANCHAL
248197
India |
| Phone |
8894660999 |
| Fax |
|
| Email |
drsthakur@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anjali |
| Designation |
PG Scholar ( Ras Shastra & Bhaishjya Kalpna Deptt.) |
| Affiliation |
RGGPG Ayurvedic College and Hospital Paprola |
| Address |
RGGPG Ayurvedic and Paprola Distt Kangra H.P.(176115)
RGGPG Ayurvedic and Paprola Distt.Kangra H.P. (176115)
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
8195990298 |
| Fax |
|
| Email |
anjalidhiman8687@gmail.com |
|
|
Source of Monetary or Material Support
|
| Baijnath pharmacy,Paprola District Kangra ,Himachal Pradesh
Charak pharmacy,Rajiv Gandhi Ayurvedic College and Hospital Paprola,District Kangra ,Himachal Pradesh
Research Institute in I.S.M. Jogindernagar,Himachal Pradesh |
|
|
Primary Sponsor
|
| Name |
Principal RGGPG Ayurvedic College and Hospital Paprola |
| Address |
RGGPG Ayurvedic College and Hospital Paprola , Kangra (H.P.) |
| 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 Manik Soni |
Rajiv Gandhi Ayurvedic College and Hospital Paprola |
Room No.207
Departmet of Kayachikitsa
RGGPG Ayurvedic College and Hospital Paprola
Kangra
HIMACHAL PRADESH |
8219121014
drmsony@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC(Human)RGGPG Ayurvedic College and Hospital Paprola |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K00-K95||Diseases of the digestive system. Ayurveda Condition: Infective Diarrhoea, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Sanjeevani Vati, Reference: Sgargdhar Samhita, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 5 Days, anupAna/sahapAna: Yes(details: Ardarka Swarsa), Additional Information: | | 2 | Comparator Arm (Non Ayurveda) | | - | Norflox TZ | It will be given for 5 days.
Route of administration: Oral
Dose :1 BD for 5 days
Follow up: after 5 days |
|
|
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Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.)Patients willing to go through trial.
2.)Patients of age group b/w 16-60 yrs of either sex.
3.)Clinically diagnosed and confirmed patients of infective Diarrhoea. |
|
| ExclusionCriteria |
| Details |
1.)Patients below the age of 16yrs and above the age of 60 yrs.
2.)Patients with severe dehydration or suffering from AIDS,Cancer,TB,IBD. |
|
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Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief in symptoms in patients of Infective Diarrhoea. |
Duration of the treatment:It will be given for 5 days.
Route of administration : Oral
Follow up: After 5 days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| General feeling of well being |
5 Days |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
16/08/2021 |
| 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="0"
Months="0"
Days="5" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 of the trial as soon as possible. Patient will be selected from campus /faculty OPD of RGGPG Ayurvedic and Paprola. Two groups of 20 patients (10 in each group) will be assessed on the basis of inclusion and exclusion criteria to know the effect of Sanjeevani Vati and Noeflox -TZ.
|