| CTRI Number |
CTRI/2021/03/031766 [Registered on: 08/03/2021] Trial Registered Prospectively |
| Last Modified On: |
06/03/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To analyze the relationship of hookworm infestation in the pathogenesis of kaphaj grahani |
|
Scientific Title of Study
|
Clinico-Etiological Study On Kaphaj Grahani With Stool Microscopic Examination With Special Reference To Hook Worm Infestation |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR PRAVEEN KUMAR SHARMA |
| Designation |
PG SCHOLAR |
| Affiliation |
PARUL INSTITUTE OF AYURVED |
| Address |
PG Department Of Roga Nidana Evum Vikriti Vigyan Parul Institute Of Ayurved Parul University P O Limda Tal Waghodia Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9074880491 |
| Fax |
02668260201 |
| Email |
p57ksharma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SUNIL R KHANDARE |
| Designation |
PROFESSOR |
| Affiliation |
PARUL INSTITUTE OF AYURVED |
| Address |
PG Department Of Roga Nidana Evum Vikriti Vigyan Parul Institute Of Ayurved Parul University P O Limda Tal Waghodia Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9421363088 |
| Fax |
02668260201 |
| Email |
drsrkhandare@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SUNIL R KHANDARE |
| Designation |
PROFESSOR |
| Affiliation |
PARUL INSTITUTE OF AYURVED |
| Address |
PG Department Of Roga Nidana Evum Vikriti Vigyan Parul Institute Of Ayurved Parul University P O Limda Tal Waghodia Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9421363088 |
| Fax |
02668260201 |
| Email |
drsrkhandare@gmail.com |
|
|
Source of Monetary or Material Support
|
| Parul Ayurved Hospital Parul Sevashram Hospital Khemdas Ayurved Hospital Parul University Po Limda Tal Waghodia Vadodara 391760 |
|
|
Primary Sponsor
|
| Name |
PARUL INSTITUTE OF AYURVED |
| Address |
PG Department Of Roga Nidana Evum Vikriti Vigyan Parul Institute Of Ayurved Parul University P O Limda Tal Waghodia Vadodara Gujarat Vadodara Gujarat 391760 India |
| 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 PRAVEEN KUMAR SHARMA |
PARUL INSTITUTE OF AYURVED |
Room No.106 Kaychikitsa Opd Room No.113 Panchakarma Opd Parul Institute Of Ayurved Parul University Po-Limda Tal- Waghodia Vadodara Gujarat
Vadodara
GUJARAT |
9074880491
p57ksharma@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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K00-K95||Diseases of the digestive system, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients having classical symptoms of Kaphaj Grahani will be selected |
|
| ExclusionCriteria |
| Details |
Patients having symptoms other than Kaphaj Grahani
Patient undertaken any antihelminthic therapy in the past 2 months at the time of presentation
Complicated cases of GIT.
Patients suffering from various complicated systemic disorders.
Patient affected from any chronic disease like carcinoma, tuberculosis, liver cirrhosis.
Pregnant and lactating women
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Find Out Relationship Of Hookworm Infestation In Pathogenesis Of Kaphaj Grahani |
1 MONTH |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Analyze The Relationship Of Hookworm Infestation In Pathogenesis Of Kaphaj Grahani |
1 MONTH |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
08/03/2021 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nill |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
INTRODUCTION
In the modern era of mechanized and computerized life, the health of a person is entirely dependent on his lifestyle, and the habit of eating.
Now a days man suffers from digestive disorders due to changes in the lifestyle, food and food habit. Digestion is not a simple process, it includes the necessary place for digestion, substrate for digestion, digestive juices and the absorbent medium like lymph and blood and the most important, place of absorption.
The description of disease Grahani in Ayurvedic literature given by different Acharyas like Charak, Sushruta or Vagabhatta can be somewhat related to the modern science disorder called mal-absorption syndro
On the basis of symptomatology Kaphaj Grahani is simulated with Hook worm infestation in modern perspective.
NEED OF STUDY
• Hook worm is a parasite that causes infection in people of all ages.
• One-fourth of the world’s population between 576 and 740 million people worldwide are infected with one of the two hookworm species Ancylostoma duodenale and Necator americanus
• Prevalence of hook worm infection ranging from 22.95 to 90%1
• However, wherever humans and animals live together, including pets, infection is possible
• So here I have decided to find out the clinico-etiology of Kaphaj Grahani one of type of Grahani with special reference to Hook worm infestation related to impaired mucosal absorption which is one of the cause of Mal-absorption syndrome with stool microscopic examination.
|