CTRI Number |
CTRI/2018/04/013527 [Registered on: 27/04/2018] Trial Registered Retrospectively |
Last Modified On: |
13/04/2018 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Ayurveda |
Study Design |
Single Arm Study |
Public Title of Study
|
Effect of Ayurvedic Formulations in the treatment of Kamala (Jaundice) |
Scientific Title of Study
|
A Clinical Study to Evaluate the Effect of Ayurvedic Formulations
in the management of Kamla (Jaundice) w.s.r. to Impaired Liver Function
|
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Prof B L Mehra |
Designation |
Prof and Head |
Affiliation |
Principal investigator Head of Kayachikitsa department |
Address |
PG DEPTT OF KAYACHIKITSA RAJIV GANDHI GOVT PG AYURVEDIC COLLEGE AND HOSPITAL PAPROLA DISTT KANGRA H P
Kangra HIMACHAL PRADESH 176115 India |
Phone |
9418017165 |
Fax |
|
Email |
mehra_bl@rediffmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Prof B L Mehra |
Designation |
Prof and Head |
Affiliation |
RG GOVT PG AYURVEDIC COLLEGE P APROLA HP |
Address |
PG DEPTT OF KAYACHIKITSA RAJIV GANDHI GOVT PG AYURVEDIC COLLEGE AND HOSPITAL PAPROLA DISTT KANGRA H P
Kangra HIMACHAL PRADESH 176115 India |
Phone |
9418017165 |
Fax |
|
Email |
mehra_bl@rediffmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Uma Thakur |
Designation |
PG Scholar |
Affiliation |
RG Govt PG Ayurvedic College Paprola H P |
Address |
PG DEPTT OF KAYACHIKITSA RAJIV GANDHI GOVT PG AYURVEDIC COLLEGE AND HOSPITAL PAPROLA DISTT KANGRA H P
Kangra HIMACHAL PRADESH 176115 India |
Phone |
9418977124 |
Fax |
|
Email |
amu.4.ut@gmail.com |
|
Source of Monetary or Material Support
|
Principal RGGPG Ayu college and hospital Paprola |
|
Primary Sponsor
|
Name |
Principal |
Address |
RGGPG Ayu college and hospital Paprola |
Type of Sponsor |
Research institution and hospital |
|
Details of Secondary Sponsor
|
Name |
Address |
Ayush Pharmaceuticals |
Ayush Pharmaceuticals and Mktg. Div. Pvt. Ltd. 30,31,32 Industrial area,Phase-1 Nagrota Bagwan Distt Kangra 176047 HP |
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Prof B L Mehra |
Paprola ayurvedic Hospital, Department of Kayachikitsa, Room No. 315 |
RGGPG Ayu. College and Hospital Paprola Distt kangra Kangra HIMACHAL PRADESH |
9418017165
mehra_bl@rediffmail.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 |
patients with impaired LFT , |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Kamalahar Yoga , Nishoth Churna with sharakara |
i.Trivrita (Nishotha) churna with Sharkara 5g twice a day for 7 days
ii. Ayurvedic formulation (syrup Kamlahar yoga) 10ml tds for 30 days
cap kamlahar yoga 500 mg bid for 30 days
|
Comparator Agent |
not aplicable |
nil |
|
Inclusion Criteria
|
Age From |
10.00 Year(s) |
Age To |
70.00 Year(s) |
Gender |
Both |
Details |
1. Patient willing to undergo trial and ready to give written consent.
2. Between the age group of 10 years and 70 years.
3. Patients presenting with signs and symptoms of Kamla and those having impaired liver function test.
4. Clinical evidence of infective hepatitis,cirrhosis of liver,parenchymal disease of liver,alcoholic liver disease etc.
|
|
ExclusionCriteria |
Details |
1.Patients not willing for trial.
2.Patients who have developed malignancy and acute hepatocellular failure.
3.Patient in whom there is need of surgery, in case of obstructive jaundice.
4.Patients who have inherited hemoglobinopathy such as sickle cell anemia or thalassemia
|
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
awaited |
June 2018 |
|
Secondary Outcome
|
Outcome |
TimePoints |
Evaluation of course of Jaundice with the given intervention, demographic pattern of the pathology |
june 2018 |
|
Target Sample Size
|
Total Sample Size="15" Sample Size from India="15"
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
|
Phase 2 |
Date of First Enrollment (India)
|
10/06/2017 |
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="11" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
Publication Details
|
none yet |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Kamala is one of the important, common clinical
entities in Ayurveda whose description appears to be most comprehensive and
incorporates the disorders of Hepato-Biliary system of Modern medicine. In
ayurvedic literature Kamla has been mentioned as sequel of PanduRoga. It occurs when Pandurogi
takes more PaitikAahar-Vihar. Jaundice is a yellowish discoloration of tissue
resulting from the deposition of bilirubin. These occur only in the presence of
serum hyperbilirubinemia and is a sign of liver disorder.
‘‘Suchimukhakrimiâ€
affecting the liver cells directly specifically mentioned in 5th
chapter of HareetSamhita. It can be correlated,thesekrimiswith the
viruses those are responsible for Viral Hepatitis. Considering the clinical
presentation of Kamala, seems near to hepatitis described in modern
medicine. Inflammation of liver (Hepatitis) can be traced to many different
causes, including viral infections, alcohol,fat accumulation in the liver, malunctioning immune system, exposure to
chemicals and other toxins and certain drugs.
Liver
is considered to be one of the vital organs which help in maintaining the
health of body. Yakrit (liver) is being described right from the Vedic period.
Modern lifestyles can over stress the liver and make it malfunctioning. The
liver diseases have remained a challenge to medical profession since many of
the liver disease may ultimately lead to irreversible changes. Liver function
tests along with liver enzymes constitute groups of tests used to determine the
state of liver function in a patient. Liver function tests are particularly
useful as a screening tool and can be a great benefit when looking for any
hepatic dysfunction.
Ayurvedicsystem
of medicine recommends various crude drugs for the treatment of hepatic
disorders. No significant and safe hepato-protective drugs are available in
modern therapeutics which can stimulate the liver function, protect it from
damage or help in improving the function of hepatic cells.The nature has
bestowed some plants with the property to prevent,treat and cure hepatic disturbances
with the interception of fewer side effects.
Taking into consideration these points
polyherbal preparations having an herbal mixture of rare herbs to improve Kamla
and liver function named as Liver Tone and Trivrita (Nishotha) Churna have been
choosen to seen their effect on the patients of Kamla (Jaundice). So, the
clinical study was planned to evaluate the hepatoprotective effect of this
herbal formulation. |