| CTRI Number |
CTRI/2024/11/076723 [Registered on: 12/11/2024] Trial Registered Prospectively |
| Last Modified On: |
09/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
TO KNOW THE RELATION OF JATARAGNI IN ARSHA ROGA |
|
Scientific Title of Study
|
Observational study to assess the status of Jataragni in Arshas |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr B SRINIVASREDDY |
| Designation |
PG Scholar ,Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital , Hassan |
| Affiliation |
PG Scholar ,Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital , Hassan |
| Address |
OPD 1 , Prakruthi OPD , DEPARTMENT OF KRIYA SHARIR
Sri Dharmasthala Manjunatheshwara college of Ayurveda and Hospital Hassan-573201
Karnataka
Hassan
KARNATAKA
573201
India |
| Phone |
8095569388 |
| Fax |
|
| Email |
srinivas80955@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pratibha V Kulkarni |
| Designation |
Professor and HOD , Sri Dharmasthala Manjunatheshwara college of Ayurveda and Hospital , Hassan |
| Affiliation |
Sri Dharmasthala Manjunatheshwara college of Ayurveda and Hospital , Hassan |
| Address |
OPD 1 , PRAKRUTHI OPD , DEPARTMENT OF KRIYA SHARIR
Sri Dharmasthala Manjunatheshwara college of Ayurveda and Hospital Hassan-573201
Karnataka
Hassan
KARNATAKA
573201
India |
| Phone |
9482175055 |
| Fax |
|
| Email |
pratibhashrinath@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pratibha V Kulkarni |
| Designation |
Professor and HOD , Sri Dharmasthala Manjunatheshwara college of Ayurveda and Hospital , Hassan |
| Affiliation |
Sri Dharmasthala Manjunatheshwara college of Ayurveda and Hospital , Hassan |
| Address |
OPD 1 , PRAKRITI , DEPARTMENT OF KRIYA SHARIR
Department of Kriya Sharir, Sri Dharmasthala Manjunatheshwara college of Ayurveda and Hospital Hassan-573201
Karnataka
Hassan
KARNATAKA
573201
India |
| Phone |
9482175055 |
| Fax |
|
| Email |
pratibhashrinath@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Dharmasthala Manjunatheshwara college of Ayurveda and Hospital Hassan. Tanniruhalla, B M Road , Hassan-573201, Karnataka , India |
|
|
Primary Sponsor
|
| Name |
DR BSrinivasreddy |
| Address |
Sri Dharmasthala Manjunatheshwara college of Ayurveda and Hospital Hassan, Tanniruhalla, B M Road, Hassan-573201,Karnataka , 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 B Srinivasreddy |
Sri Dharmasthala Manjunatheshwara College Of Ayurveda And Hospital, Hassan |
OPD 1 , Prakriti, Department of Kriya Sharir
Hassan
KARNATAKA |
8095569388
srinivas80955@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| nstitutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K928||Other specified diseases of the digestive system. Ayurveda Condition: ARSAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.subjects between the age group 18-50 years irrespective of gender
2.subjects who are diagnosed with arshas( both abhyantara and bahya )
3. subjects wiliing to participate the study |
|
| ExclusionCriteria |
| Details |
1.Pregnant woman
2.Congenital anomalies if any
3.Those who have systemic diseases like diabetes mellitus, hypertension, hypothyroidism, thyrotoxicosis, metabolic diseases, malignancy, and other such multisystem disorders.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
status of jataragni in arshas
|
4 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
status of jataragni in arshas
|
8 weeks
|
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
21/11/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
SUMMARY TITLE: “OBSERVATIONAL STUDY TO ASSESS THE STATUS OF JATARAGNI IN ARSHASâ€. AIMS AND OBJECTIVES OF THE STUDY: • To assess the status of Jataragni in Arshas JUSTIFICATION FOR STUDY The concept of Agni delivers essential knowledge for understanding the theories of Ayurveda namely Ahara Pacana, Dhathu Utpatti, Vyadhi Utpatti . Improper functioning of Agni leads to Agni Dusti which is the major causative factor for many diseases. Prashama or Prakopa of Dosas, Dhathu and Mala are depended on the status of Agni. There are 4 functional states of Jataragni such as Sama, Vishama, Theekshna and Manda. Importance of Agni has been seen in both the healthy and diseased conditions. Arsha is a clinical condition in which structural derangement take place, during process of pathogenesis the doshas are vitiated due to indulgence in etiological factors by the person that in turn leads to Agnimandya that further hampers the functions of Apana Vayu. Present time is the era of fast foods, irregularity in foods timing, changing of food style, sedentary life style and mental stress all the factors disturb the digestive system resulting in vitiation of Doshas and localized in the Mamsa and Meda of Guda Pradesha leading to Arsha. So, for this study is being undertaken to assess the status of Jataragni in Arsha Vyadi . METHODOLOGY • It is an observational study. • Sampling method: convenient sampling 150 subjects visiting OPD and IPD of Sri Dharmasthala Manjunatheshwara College of Ayurveda & Hospital, Hassan will be selected and given with questionnaires for JATARAGNI assessment.
|