| CTRI Number |
CTRI/2024/11/077253 [Registered on: 25/11/2024] Trial Registered Prospectively |
| Last Modified On: |
19/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To Understand the Etiopathology of Jaundice Through changes in Liver Function Test |
|
Scientific Title of Study
|
An Approach to Etiopathological Diagnostic Study
on Koshtashakashrita Kamala of Raktavaha
Srotodushti Through Liver Function Test |
| 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 Desai Ravina Chandubhai |
| Designation |
M D Scholar Roga Nidan and Vikruthi Vijnana |
| Affiliation |
Government Ayurvedic Medical College |
| Address |
Government Ayurvedic Medical College, Dhanvantri Road, Bangalore
Bangalore KARNATAKA 560009 India |
| Phone |
9512895212 |
| Fax |
|
| Email |
desairavina2210@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sudeesha J |
| Designation |
Assistant Professor |
| Affiliation |
Government Ayurvedic Medical College |
| Address |
Opd No- 7A ,Department of Roganidan, Government Ayurvedic Medical College, Dhanvantri Road, Bangalore
Bangalore KARNATAKA 560009 India |
| Phone |
9481818631 |
| Fax |
|
| Email |
drsudeeshshetty@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Sudeesha J |
| Designation |
Assistant Professor |
| Affiliation |
Government Ayurvedic Medical College |
| Address |
Opd No- 7A ,Department of Roganidan, Government Ayurvedic Medical College, Dhanvantri Road, Bangalore
Bangalore KARNATAKA 560009 India |
| Phone |
9481818631 |
| Fax |
|
| Email |
drsudeeshshetty@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurvedic Medical College, Dhanvantri Road, Bangalore,Karnataka,India-560009 |
|
|
Primary Sponsor
|
| Name |
Government Ayurvedic Medical College |
| Address |
Government Ayurvedic Medical College, Dhanvantri Road, Bangalore, Karnataka-560009 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Desai Ravina Chandubhai |
Government Ayurvedic Medical College |
Opd No- 7A ,Department of Roganidan, Government Ayurvedic Medical College, Dhanvantri Road, Bangalore,Karnataka,India-560009 Bangalore KARNATAKA |
9512895212
desairavina2210@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Government Ayurvedic Medical College, Dhanvantri Road, Bangalore-560009 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K769||Liver disease, unspecified. Ayurveda Condition: KAMALA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients between age group of 18 to 70 years
Patients who satisfied the diagnostic criteria |
|
| ExclusionCriteria |
| Details |
Patients suffering from other systemic diseases like Diabetes mellitus, hypertension, HIV, TB etc.
2. Patients suffering from secondary disorders of liver like liver cirrhosis, hyperbilirubinemia due to autoimmune disorders etc.
3. Pregnant ladies. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Understand the Etiopathogenesis of Koshtashakashrita Kamala Through Liver Function Test |
Nil |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Evaluate the changes of Liver Function Test in Koshtashakashrita Kamala |
Nil |
|
|
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)
|
02/12/2024 |
| 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="5" 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
|
Kamala is a Pittaja Nanatmaja Vyadhi, comes under Raktapradoshaja Vikara. If Rakta get vitiated by the doshas then it leads to Raktapradoshaja Vikara like kamala. Yakrit, Pleeha and Raktavaha Dhamani are considered as Moolasthana of Raktavaha srotas . In today’s era, the changing life style and eating pattern like Viruddhaahara, Asatmya bhojana, Vidahi annapana etc, causes Vikruti of Pitta Dosha. Due to ashraya-ashrayi bhava does the prakopa of Rakta , which makes them to affect with Raktavaha Srotodushti and does the Dagdhata of Rakta and Mamsa resulting in the manifestation of kamala. In koshtashakhashrita kamala due to Swatantra Nidana Pitta Dosha get vitiated mainly the Ranjaka Pitta present in Raktadi dhatu and Koshta get vitiated and produces the lakshanas like Haridra Netra,Nakha,Twaka,Mutra,Anana etc. These symptoms are similar to Jaundice. Jaundice is characterized by yellowish discoloration of body tissue resulting from the accumulation of excess bilirubin. Prevalence of Jaundice Acc. to American Roentgen Ray Society image of Jaundice epidemiology and demographics is approximately 40%. Liver is a dual organ having both secretory and excretory functions , Liver perform various functions in maintaining homeostasis and health. These functions include the synthesis of albumin, certain enzymes, bile and its constituents, metabolism of bilirubin etc. When the liver is diseased, one or more of its functions are impaired result in elevated levels of its constituents. Here an attempt is made to understand the Vishesha samprapti and Diagnosis of Koshtashakhashrita kamala and to know the Role of Parinama bhavas of Raktavaha Srotodushti and to assess the changes in Liver Function Test. |