| CTRI Number |
CTRI/2024/11/077204 [Registered on: 21/11/2024] Trial Registered Prospectively |
| Last Modified On: |
27/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the effect of conventional medicines in liver disorders with blood purifiers as mentioned in Ayurveda |
|
Scientific Title of Study
|
A randomized comparative trial with Rakta Prasadak Ausadha in Yakrita Dushti for validation of Garbhasya yakratpleehano shonitajo |
| 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. Ritika |
| Designation |
MD Scholar (Rachana Sharir) |
| Affiliation |
National Institute of Ayurveda |
| Address |
Department of Rachana Sharir
National Institute of Ayurveda
Jaipur, Rajasthan
Pin code - 302002 National Institute of Ayurveda
Jaipur, Rajasthan
Pin code - 302002 Jaipur RAJASTHAN 302002 India |
| Phone |
8619346220 |
| Fax |
|
| Email |
ritikakaswa830@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr. Neha Udainiya |
| Designation |
Assistant Professor |
| Affiliation |
National Institute of Ayurveda |
| Address |
Department of Rachana Sharir
National Institute of Ayurveda
Jaipur, Rajasthan
pin code 302002 National Institute of Ayurveda
Jaipur, Rajasthan
pin code 302002 Jaipur RAJASTHAN 302002 India |
| Phone |
8607429931 |
| Fax |
|
| Email |
neha.rs@nia.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Dr. Neha Udainiya |
| Designation |
Assistant Professor |
| Affiliation |
National Institute of Ayurveda |
| Address |
Department of Rachana Sharir
National Institute of Ayurveda
Jaipur, Rajasthan
pin code 302002 National Institute of Ayurveda
Jaipur, Rajasthan
pin code 302002
RAJASTHAN 302002 India |
| Phone |
8607429931 |
| Fax |
|
| Email |
neha.rs@nia.edu.in |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda
Jaipur, Rajasthan India
pin code 302002 |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda |
| Address |
National Institute of Ayurveda
Jaipur, Rajasthan
pin code 302002 India |
| 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 |
| Dr Ritika |
National Institute of Ayurveda, Jaipur |
OPD No. 3 SSBH Department of Rachana Sharir
National Institute of Ayurveda, Jaipur Jaipur RAJASTHAN |
8619346220
ritikakaswa830@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, National Institute of Ayurveda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K769||Liver disease, unspecified. Ayurveda Condition: RAKTAVAHASROTODUSHTIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: SARIVAGHAN VATI, Reference: PRIYANIGHANTU, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -WATER), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: ROHITAKGHAN VATI, Reference: BHAVPRAKASH NIGHANTU, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -WATER), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient with already known case of any liver disorders (pre-hepatic and hepatic cause) with deranged LFT (liver function test) values falling in the range.
2. Patient of either sex having age between of 18 to 50 yrs.
3. Patients who are willing to sign consent form for the trial |
|
| ExclusionCriteria |
| Details |
i. Patients below age of 18 yrs and above 50 yrs.
ii.Patient with k/c/o uncontrolled Diabetes, Hypertension, Carcinoma, etc.
iii. Patients with post hepatic conditions such as common bile duct obstruction, liver cirrhosis, bile duct tumor, carcinoma of pancreas head, etc.
iv. Patient participated in any clinical trial with in last six months.
V. Pregnant or lactating women |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| CLASSICAL SIGN AND SYMPTOMS OF YAKRITA DUSHTI AS PER SAMHITA |
after 4week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Based upon the changes in liver function test, CBC, TEC |
15 days |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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)
|
01/12/2024 |
| 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="1" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Purpose of study: Liver disease accounts for 2 million deaths annually(cirrhosis, viral hepatitis, and liver cancer) and is responsible for 4% of all deaths (1 out of every 25 deaths worldwide); approximately two-thirds of all liver related deaths occur in men & 1 out of 3 liver-related deaths occur among females Within this estimate, liver cancer accounts for 600,000 to 900,000 deaths. 1 Currently liver disease is the eleventh-leading cause of death, but liver deaths may be underestimated. 2 Liver disease is fast spreading like an epidemic in India with one out of every five adults getting affected. Liver related deaths in India have reached a staggering figure of 268,580 (3.17% of all deaths) per year contributing to 18.3% of global liver-related deaths that account over 2 million deaths globally per year. 3 There are more than a hundred different liver diseases of diverse nature that are being identified as the leading causes of disability, disease, and death globally. ï‚— Liver diseases are broadly caused by hepatitis viruses (A to E), alcohol, non-alcoholic fatty liver disease (NAFLD), drugs, autoimmune and genetic diseases, cryptogenic and liver tumors-benign and malignant. ï‚— Liver deaths occur predominantly because of liver cirrhosis, acute liver failure, and liver cancer In Ayurveda, much attention has been given to Anga-Avayava Utpatti in Garbha Avakranti Sharira4. Garbha Avakranti refers to the growth of the Garbha in Garbhavastha. The discipline of medicine known as embryology studies the formation of the human embryo and its development inside the uterus until the delivery of a child. Different opinion exists regarding Anga-Avayava Utpatti by various Acharya. Acharya Sushruta, while describing the formation of organs in the foetus, has mentioned that the Yakrita (liver), Pleeha (spleen) are developed from Shonita.5 In Kashyap Samhita, it has been mentioned that during Anga- Avayava Utpatti (development of different organs in fetus) Hardiya is formed from Shonita, Yakrita from Hardiya, Pleeha is formed from Yakrita, and from Pleeha Fuffus is formed. As per Samhitas, Shonita is involved in development of different Anga- Avayava. We has observed that in particular diseases like Pandu (anaemia), Pleeharoga (splenomegaly), Twak Vikara (skin disorder), Kamala (jaundice), etc, Yakrita and Pleeha are affected where Shonita is the common factor. Some studies have been done & it has been observed that Shonita is a common factor in the diagnosis and treatment of diseases. Some drugs like Lauha Bhasma, Tamra Bhasma, Manjistha, Shatavari, and Punarnava, which are used for Shonita, can be beneficial for the diseases of Yakrita, and Pleeha.6 During the treatment of the Yakrita dushti (liver disorders), we mainly focus on those drugs which are mentioned under the heading of Yakrita Rogadhikar. We always ignore the concept of embryogenesis i.e. Shonita is responsible for the formation of Yakrita. This study mainly focuses on that concept & seeks to know the effect of Rakta Prashadhak Aushodha on Yakrita dushti.
NEED TO STUDY 1. There is a need to explore the fundamental principles related to Anga-Avyava Utpatti under the lens of clinical utility. 2. The Samhita principles of embryogenesis need to be re-validated and established. 3. The prevalence of morbidity & mortality of liver diseases is currently very high and there is a lack of effective treatment for curing the disorder so there is a need to discover new drugs & concept of treatment. 4. There is a need to focus on the concept of Rakta Prashadhan in liver disorders as we mainly follow the treatment concept of Yakrita dushti, that focus on drugs those are mentioned under Yakrita Rogadhikar. |