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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  
Status 
Not Applicable 
 
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.             

       ‘‘Suchimukhakrimi” 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.

 
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