| CTRI Number |
CTRI/2023/05/053263 [Registered on: 30/05/2023] Trial Registered Prospectively |
| Last Modified On: |
25/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Effect of low blood level on digestive capacity of individuals |
|
Scientific Title of Study
|
An Observational Prospective study to evaluate the impact of Rakta kshaya on Agnibala |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sakshi |
| Designation |
MD scholar |
| Affiliation |
Shri Krishna Govt. Ayurveda college and Hospital |
| Address |
PG department of Kriya Sharir, Shri Krishna Govt. Ayurvedic college and hospital, sector 8, Umri road ,Kurukshetra ,136118, Haryana
Kurukshetra
HARYANA
136118
India |
| Phone |
7404462599 |
| Fax |
|
| Email |
sakshi96saini@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sakshi |
| Designation |
MD scholar |
| Affiliation |
Shri Krishna Govt. Ayurveda college and Hospital |
| Address |
PG department of Kriya Sharir, Shri Krishna Govt. Ayurvedic college and hospital, sector 8, Umri road ,Kurukshetra ,136118, Haryana
Kurukshetra
HARYANA
136118
India |
| Phone |
7404462599 |
| Fax |
|
| Email |
sakshi96saini@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sakshi |
| Designation |
MD scholar |
| Affiliation |
Shri Krishna Govt. Ayurveda college and Hospital |
| Address |
PG department of Kriya Sharir, Shri Krishna Govt. Ayurvedic college and hospital, sector 8, Umri road ,Kurukshetra ,136118, Haryana
Kurukshetra
HARYANA
136118
India |
| Phone |
7404462599 |
| Fax |
|
| Email |
sakshi96saini@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Krishna Govt. Ayurvedic College and Hospital, Kurukshetra |
|
|
Primary Sponsor
|
| Name |
Shri Krishna Govt. Ayurvedic College and Hospital |
| Address |
Shri Krishna Govt. Ayurvedic College and Hospital, Sector 8, Umri road ,Kurukshetra ,136118,Haryana |
| Type of Sponsor |
Government 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 Shubha Kaushal |
Shri Krishna Govt. Ayurvedic College and Hospital, Sector 8, umri road, Kurukshetra,136118 |
Room no.10,PG Department of Kriya Sharir, Shri Krishna Govt. Ayurvedic College and Hospital, Sector 8, Umri road , Kurukshetra ,136118
Kurukshetra
HARYANA |
8901184522
shubha_kaushal@rediffmail.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 |
| Patients |
(1) ICD-10 Condition:D539||Nutritional anemia, unspecified. Ayurveda Condition: PANDU-PURVARUPAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1)Subjects between the age group of 20 -40yrs.
2)Hb gm% 6-10gm/dl in both genders. |
|
| ExclusionCriteria |
| Details |
1)Hb % below 6gm/dl and above 10gm/dl
2)Pregnancy and Lactation.
3)History of Cardiovascular disorders.
4)History of Respiratory disorders.
5)History of Major surgery in the recent past.
6)History of Prolonged medicine intake.
History of Alcohol and Smoking .
Hyper and Hypothyroidism. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the rakta kshaya lakshans in individuals. |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the status of Agni in relation to rakta kshaya. |
Baseline |
|
|
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)
|
22/06/2023 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In today’s era ,lifestyle and wrong food habits are increasing the prevalence of Rakta kshaya in
all age groups.Mainly youth have easy access to unhealthy dietary choices which is leading to
deterioration of their digestive capacity (Agni bala).
Agni bala is the fundamental concept on which physiological health of individuals
depends.Imbalance in the physiology of agni is the main cause for the formation of ama, which
leads to the formation of undigested Rasa dhatu .
Jatharagni helps in the digestion of food and aahar rasa formation, which by the action of
rasagni is transformed into rasa dhatu, and further each dhatu gradually transforms into
successive dhatus with the help of their respective agni’s ,called by the Dhatu’s name for eg.
Rasagni for Rasa dhatu, Rakta Agni for Rakta Dhatu .
Need of study is to understand and correlate the impact of agni bala in dhatu nirmaan kriya
w.s.r to Rakta Dhatu. |