| CTRI Number |
CTRI/2024/12/078212 [Registered on: 17/12/2024] Trial Registered Prospectively |
| Last Modified On: |
17/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical Study on SHARAPUNKHA In the Management of Nonalcoholic fatty Liver disease |
|
Scientific Title of Study
|
A Pharmaco clinical and Phytochemical study on SHARAPUNKHA(Tephrosia purpurea)in the management of early stage of Yakrutodara w.s.r to Nonalcoholic fatty liver disease |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
JISHNU TK |
| Designation |
PG RESIDENT |
| Affiliation |
Ayurveda and Unani tibbia college |
| Address |
Department of Dravyaguna vigyan Ayurveda and Unani Tibbia college New delhi,Karolbagh,
New Delhi
DELHI
110005
India |
| Phone |
9995635526 |
| Fax |
|
| Email |
jishnukpuram.ayu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Banshidhar Behera |
| Designation |
Associate professor |
| Affiliation |
Ayurveda and Unani Tibbia college New delhi |
| Address |
Department of Dravyaguna vigyan Ayurveda and Unani Tibbia college karolbagh New delhi
New Delhi
DELHI
110005
India |
| Phone |
9414458895 |
| Fax |
|
| Email |
drbanshi@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Banshidhar Behera |
| Designation |
Associate professor |
| Affiliation |
Ayurveda and Unani Tibbia college New delhi |
| Address |
Department of Dravyaguna vigyan Ayurveda and Unani Tibbia college karolbagh New delhi
New Delhi
DELHI
110005
India |
| Phone |
9414458895 |
| Fax |
|
| Email |
drbanshi@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Ayurveda and Unani Tibbia college Hospital OPD,Ajmal khan road,karolbagh ,new delhi ,india,110005 |
|
|
Primary Sponsor
|
| Name |
Ayurevda and Unani Tibbia college |
| Address |
Ayurveda and Unani Tibbia college karolbagh New Delhi |
| Type of Sponsor |
Government 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 |
| DrJishnu TK |
Ayurveda and Unani Tibbia college and Hospital Newdelhi |
OPD no 18 Ayurveda and Unani Tibbia college karolbagh New delhi
New Delhi
DELHI |
9995635526
jishnukpuram.ayu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Ayurvedic and Unani Tibbia college and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K760||Fatty (change of) liver, not elsewhere classified. Ayurveda Condition: YAKRUDDALYUDARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Sharapunkha(Tephrosia purpurea), Reference: Bhavaprakasha nighandu,Madanapala nighandu,Gadhanigraha, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Luke warm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patient of either sex between the age of 20 - 70 years suffering from Non alcoholic fatty liver disease grade 1 and 2 0r Diagnosed case of NAFLD Grade 1 and 2 reporting to General OPD of Tibbia college hospital |
|
| ExclusionCriteria |
| Details |
1 Patient having H/O cardiovascular diseases and patient with uncontrolled HTN(BP being persistently above 140/90 mm Hg despite medication
2 Patient with uncontrolled diabetes and those who are on insulin therapy
3 pregnant and lactating patients
4 patients with communicable diseases like TB, varicella zoster etc
5 other hepatic pathologies (Eg-jaundice)or patient with elevated level of bilirubin etc. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
parameter for assessment of study outcome
objective criteria includes LFT,USG,Fibroscan
Improvement in subjective criteria likes Fatigue,Pain in epigastrium,Anorexia,Nausea |
3 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluating the safety of drug Sharapunkha(Tephrosia purpurea) which will be assessed with KFT |
After 15 the day of trail and completion of trail ie 3 month |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
01/01/2025 |
| 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 Applicable |
| 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
|
Non alcoholic fatty liver disease is prevalent and concerning health condition characterized by accumulation of fat in the liver of individuals who consume little or no alcohol .Often associated with obesity ,poor diet and sedentary life style .NAFLD ranges from simple fatty liver more severe conditions like non alcoholic steatohepatitis (NASH) and cirrhosis .Numerous risk factors for the development of NAFLD have been explained .Most have some form of metabolic derangement or insulin resistance at the core of its pathophysiology .Estimate have been posited suggesting the incidence of NAFLD to be 20% -30% in western countries and 5% to 18% in Asia. In general Indian population the prevalence of NAFLD is estimated to be around 9% -32% ,with higher incidence rate among obese and diabetic patients .NAFLD is defined as the presence of hepatic steatosis with no evidence of hepatocellular injury in the form of ballooning of hepatocytes. Description of yakrut related disease are minimum in ayurveda .The common disease is yakrutodara .Yakrut is an important organ in body ,it perform various function in the body .NAFLD can be considered as the early stage of yakrutodara where sama meda dhathu formation and its accumulation occur in yakrut .sedentary life style being one of the major factor in the pathogemesis of NAFLD . The plant sharapunkha (Tephrosia purpurea) is highly branched ,herbaceous ,suberect,perennial herb , widely grown in india.The description of sharapunkha mainly seen in Nighandu period .Bhavaprakasha nighandu,Madanapala nighandu, etc. explained the medicinal properties of sharapunkha which mainly includes Ykrutrogahara ,pleeharoga hara etc. This study aimed to evaluate the efficacy of sharapunkha in the management of early stages yakrutodara with special reference to Non alcoholic fatty liver disease |