| CTRI Number |
CTRI/2020/02/023418 [Registered on: 18/02/2020] Trial Registered Prospectively |
| Last Modified On: |
17/02/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical evaluation of Shunthi Siddha Jal in Kapha Prakop symptoms in vasant ritu. |
|
Scientific Title of Study
|
“Efficacy Of Shrungaberambu In Vasanta Ritu With Special Reference To Ashtanga Hridayam – A Randomized Clinical Trial†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shital Pramod Pachpute |
| Designation |
PG second year student |
| Affiliation |
Dr.D.Y.Patil College Of Ayurved And Research Centre. Pimpri,Pune |
| Address |
Samhita Siddhant Department 4th floor Dr.D.Y.Patil college of ayurveda and research centre Pimpri pune 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9309168260 |
| Fax |
|
| Email |
missshital25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shital Rasane |
| Designation |
Associate professor Samhita Sidhhant department |
| Affiliation |
Dr.D.Y.Patil College Of Ayurved And Research Centre. Pimpri,Pune |
| Address |
Samhita Siddhant Department 4th floor Dr.D.Y.Patil college of ayurveda and research centre Pimpri pune 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9503330831 |
| Fax |
|
| Email |
shitalrasane@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shital Pramod Pachpute |
| Designation |
PG second year student |
| Affiliation |
Dr.D.Y.Patil College Of Ayurved And Research Centre. Pimpri,Pune |
| Address |
Samhita Siddhant Department 4th floor Dr.D.Y.Patil college of ayurveda and research centre Pimpri pune 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9309168260 |
| Fax |
|
| Email |
missshital25@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.D.Y.Patil college of ayurved and research centre, Pimpri Pune |
|
|
Primary Sponsor
|
| Name |
DrDYPatil college of ayurved and research centre Pimpri pune |
| Address |
Santa Tukaram Nagar Pimpri, Pune |
| Type of Sponsor |
Private medical college |
|
|
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 Shital Pramod Pachpute |
Dr.D.Y.Patil college of ayurveda and research centre Pimpri pune 411018 |
Santa Tukaram Nagar Pimpri Pune
Pune
MAHARASHTRA |
9309168260
missshital25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Persons |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
normal water |
30 healthy volunteers will be taken for normal water drink |
| Intervention |
shrungaberambu |
30 healthy volunteers will be taken for shrungaberambu pana |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Normal Healthy Individuals |
|
| ExclusionCriteria |
| Details |
Pitta Dominated prakruti volunteers will be excluded.
Volunteers with any major disease and those who are on regular medicines.
Those who are not willing to participate in clinical study. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of shunthi siddha jal in kapha prakop symptoms in vasant ritu. |
Every week after 1st visit |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of shunthi siddha jal with normal water |
Every week after 1st visit |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
24/02/2020 |
| 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="10" |
|
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)?
|
|
Brief Summary
|
In today’s era there is increasing percentage of lifestyle related disorders. Hence, if we follow the allotted seasonal "Ritucharya", it may decrease and also may prove to be important for a healthy living. |