| CTRI Number |
CTRI/2020/04/024783 [Registered on: 22/04/2020] Trial Registered Prospectively |
| Last Modified On: |
21/04/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Other (Specify) [Sira Vedha] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Sira Vedha on Non Alcoholic Fatty Liver Diseases |
|
Scientific Title of Study
|
The effect of SiraVedha at Dakshin Kurpar Sandhi in the management of Non Alcoholic Fatty Liver Diseases |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gaurav Sawarkar |
| Designation |
Associate Professor |
| Affiliation |
Department of Rachana Sharir Mahatma Gandhi Ayurved College Hospital and Research Centre |
| Address |
M1 14 Meghdoot Sawangi Meghe Wardha 442001
Salod Hirapur Wardha 442001
Wardha
MAHARASHTRA
442001
India |
| Phone |
8956977899 |
| Fax |
|
| Email |
drsawarkar.gaurav@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priti Desai |
| Designation |
Professor |
| Affiliation |
Department of Rachana Sharir Mahatma Gandhi Ayurved College Hospital and Research Centre |
| Address |
Mahatma Gandhi Ayurved College Hospital and Research Centre Wardha Maharashtra
Salod Hirapur Wardha 442001
Wardha
MAHARASHTRA
442001
India |
| Phone |
9923020425 |
| Fax |
|
| Email |
drprdesai@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gaurav Sawarkar |
| Designation |
Associate Professor |
| Affiliation |
Department of Rachana Sharir Mahatma Gandhi Ayurved College Hospital and Research Centre |
| Address |
Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Hirapur Wardha 442001
Salod Hirapur Wardha 442001
Wardha
MAHARASHTRA
442001
India |
| Phone |
9923020425 |
| Fax |
|
| Email |
drsawarkar.gaurav@gmail.com |
|
|
Source of Monetary or Material Support
|
| Patient and Sira Vedha Material Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Hirapur Wardha Maharashtra India |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Medical Sciences Deemed to be University |
| Address |
Sawangi Meghe Wardha |
| Type of Sponsor |
Other [Datta Meghe Institute of Medical Sciences Deemed to be University Sawangi Meghe Wardha Maharashtra] |
|
|
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 GAURAV SAWARKAR |
Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Hirapur Wardha |
Department of Rachana Sharir
Wardha
MAHARASHTRA |
8956977899
drsawarkar.gaurav@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DMIMS Deemed to be University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R688||Other general symptoms and signs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Lifestyle modification and diet regime |
Control that will be treated with lifestyle modification and diet regime |
| Intervention |
Siravedha |
Sira Vedha and lifestyle modification and diet regime.
65 ml blood will be withdrawn per setting
3 setting in interval of 15 days
Duration of therapy 30 days |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria for the study include a) All patients irrespective of sex having age between 20 to 50 years with Non-Alcoholic Fatty Liver Disease (Grade I & Grade II fatty liver), b) able to give informed consent and willingness to participate in follow-up. |
|
| ExclusionCriteria |
| Details |
Exclusion criteria for the study include- patients with carcinoma of liver, liver cirrhosis, HIV positive, HBsAg positive, terminal illness, pregnant and lactating lady, accidental cases, all types of anemias, Hemophilia, Thalassemia, case of poisoning, alcoholic liver diseases, eczema over Rt. elbow joint, skin diseases/ allergy, injury at right elbow joint. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary objective is to study the effect of Sira Vedha at Right Elbow Joint in the management of Non-Alcoholic Fatty Liver Diseases as an adjuvant therapy. |
Baseline 30th day 60th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| a) To study the effect of Sira Vedha at Right Elbow Joint on Liver Function, lipid profile, CBC count in Non-Alcoholic Fatty Liver Diseases in study group, b) To study the effect of Sira Vedha at Right Elbow Joint on Liver Function, lipid profile, CBC count in Non-Alcoholic Fatty Liver Diseases in control group, c) To compare the effect of Sira Vedha at Right Elbow Joint by evaluating the values of Liver Function, lipid profile, CBC count in study and control group. |
Baseline 30th day 60th day |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
30/04/2020 |
| 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
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Background: Sushruta
explained the Sira Vedha at Dakshin Kurpara Sandhi (Right Elbow Joint) as a
remedy for Yakrit Vikara (Liver Diseases), same treatment was explained by
modern science, but exact site was not mentioned. Similarly, the amount to be
withdrawn and interval also not revealed by previous researches. Although, in
ancient science, same was explained in the context, but lack clinical evidences
it was missing in mainstream. So, it is the need of time to study the principal
of Sushruta regarding treatment of liver diseases.
Objective: To
study the effect of Sira Vedha at Dakshin Kurpara Sandhi (Right Elbow
Joint) in the management of Non-Alcoholic Fatty Liver Diseases as an adjuvant
therapy
Material and Method: 120
patients will be randomly allotted to Group A & Group B having 60 patients
each group. Group A will be treated with only lifestyle modification and diet
regime and Group B, Sira Vedha with lifestyle modification and diet regime.
Sira Vedha will be done at three times by the interval of fifteen days and LFT,
lipid profile and CBC investigations will be carried out with respect to
regular visit. Analysis will be done after the last visit of the patient for
the anticipative outcome of the Sira Vedha in present scenario. |