| CTRI Number |
CTRI/2024/08/072611 [Registered on: 19/08/2024] Trial Registered Prospectively |
| Last Modified On: |
08/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trial to study the effect of two medicines Vaishwanara Choornam and aqueous extract of Drakshadi Kashayam in patients with Non-Alcoholic Fatty Liver Disease |
|
Scientific Title of Study
|
Effectiveness of Vaishwanara Choornam and Drakshadi Kashayam aqueous extract in Non-Alcoholic 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 |
Dr Nidhish Nair |
| Designation |
PG Scholar, Department Of Kayachikitsa |
| Affiliation |
Government Ayurveda Medical College and Hospital, Thiruvananthapuram |
| Address |
Department Of Kayachikitsa, Ground Floor,OPD No.2,Room No 2, Government Ayurveda Medical College and Hospital, Pulimoodu Junction,Thiruvananthapuram,Kerala
Thiruvananthapuram KERALA 695001 India |
| Phone |
9995274816 |
| Fax |
|
| Email |
dr.nidhishnair@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Nidhish Nair |
| Designation |
PG Scholar, Department Of Kayachikitsa |
| Affiliation |
Government Ayurveda Medical College and Hospital, Thiruvananthapuram |
| Address |
Department Of Kayachikitsa,Ground Floor,OPD No.2,Room No 2, Government Ayurveda Medical College and Hospital, Pulimoodu Junction, Thiruvananthapuram, Kerala
Thiruvananthapuram KERALA 695001 India |
| Phone |
9995274816 |
| Fax |
|
| Email |
dr.nidhishnair@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr K Ambika |
| Designation |
Professor and H.O.D,Department Of Kayachikitsa |
| Affiliation |
Government Ayurveda Medical College and Hospital, Thiruvananthapuram |
| Address |
Department Of Kayachikitsa, Ground Floor,OPD No.2,Room No: 2, Government Ayurveda Medical College and Hospital, Pulimoodu Junction, Thiruvananthapuram, Kerala
Thiruvananthapuram KERALA 695001 India |
| Phone |
9847457084 |
| Fax |
|
| Email |
ambikachitharanjan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurveda Medical College and Hospital,Pulimoodu Junction, Thiruvanathapuram, Kerala,India,Pincode:695001 |
|
|
Primary Sponsor
|
| Name |
NIDHISH NAIR |
| Address |
Government Ayurveda College and Hospital, Pulimoodu Junction, Thiruvananthapuram, 695001, Kerala, India, Department of Kayachikitsa, OP. |
| Type of Sponsor |
Other [Self] |
|
|
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 Nidhish Nair |
Government Ayurveda Medical College and Hospital |
Department Of Kayachikitsa,Ground Floor,OPD No.2,Room No 2,Pulimoodu Junction,Thiruvananthapuram, Kerala, 695001,India Thiruvananthapuram KERALA |
9995274816
dr.nidhishnair@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee(IEC),Government Ayurveda Medical College and Hospital Thiruvananthapuram,Kerala,India |
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: Drakshadi Kashayam, Reference: Ashtangahrudayam,Chikitsasthanam,Jwarachikitsa,Chapter No:1,Shloka No:55, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 96(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 2 Months, anupAna/sahapAna: No, Additional Information: -(2) Medicine Name: Vaishwanara Choornam, Reference: Ashtangahrudayam,Chikitsasthanam,Gulmachikitsa,Chapter No14,ShlokaNo:34, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: Ushnambu), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Male and Female participants of age group between 25-65 years of age having Grade 1 and Grade 2 Non-Alcoholic Fatty Liver Disease diagnosed through ultrasonography. |
|
| ExclusionCriteria |
| Details |
Known history of any serious systemic illnesses.
Pregnant and lactating women
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in grades of fatty liver as identified by echogenicity of liver through USG abdomen. |
60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Reduction in Elevated Liver Enzymes.
Reduction in NAFLD Fibrosis Score. |
60days |
|
|
Target Sample Size
|
Total Sample Size="20" Sample Size from India="20"
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)
|
19/08/2024 |
| 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="0" Months="2" 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
(NAFLD) has a global prevalence of 25% and is a leading cause of cirrhosis and
hepatocellular carcinoma. NAFLD encompasses a disease continuum from steatosis
with or without mild inflammation (non-alcoholic fatty liver), to non-alcoholic
steatohepatitis (NASH), which is characterized by necroinflammation and faster
fibrosis progression, NAFLD has a bidirectional association with components of
the metabolic syndrome, and type 2 diabetes increases the risk of cirrhosis and
related complications NAFLD may be corelated
with Satarpana janya vyadhis due to intake of nidanas there is
resultant agnimandyam causing ama formation and vitiation of Kapha
and medas leading to accumulation in Yakrith which is Pittasthana
as the disease advances it can result
in Dhatupaka (necroinflammation) NASH , the final phase of the disease
is characterized by increase of Vata Gunas resulting in fibrosis &
cirrhosis.Hence the medicines selected should possess
the qualities like deepana,pachana, srothosodhana,vatanulomana and yakruthprasadana. The study drug Vaishwanara choornam,and
Drakshadi Kashyam mentioned in Ashtang Hrudya gulma chikitsa and jwara
chikitsa respectively ,the formulation will be prepared according to the methods adopted from
classical Ayurvedic textbooks for choornam and in dose adjusted Kashaya aqueous
extract form with date of administration labelled in it for 60 days. An
interventional pre – post study in a single group will be conducted in
participants attending OPD of Department of Kayachikitsa at Government Ayurveda
College, Thiruvananthapuram. Participants will be advised to take Vaishwanara Choornam in dose of 6g
with Drakshadi Kashyam administered as whole Kashaya aqueous extract at
a dose of 3gm (1 sachet) with 96 ml lukewarm water twice daily at 6AM,6PM for a
period of 60 days. A total of 120 kashaya aqueous extract sachet and 120
packets of vaishwanara choornam, 30 packets of aqueous extract of kashayam and 30 packets of choornam will be
given to the participants in each visit at an interval of 15days.After
collecting baseline data participant will be evaluated on the 0th and 61st day. USG, Scoring and
Blood parameters are done before and after the study. The results obtained will
be statistically analyzed and concluded.
|