| CTRI Number |
CTRI/2024/12/077999 [Registered on: 12/12/2024] Trial Registered Prospectively |
| Last Modified On: |
11/12/2024 |
| 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 Triphaladi Yoga And Dhatriloha Yoga In Management Of Bahupitta kamala Hepatocellular Jaundice |
|
Scientific Title of Study
|
A Randomized Controlled Clinical Study To Evaluate The Efficacy Of Triphaladi Yoga And Dhatriloha Yoga In Management Of Bahupitta kamala Hepatocellular Jaundice |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pratik Narendra Runwal |
| Designation |
PG SCHOLAR |
| Affiliation |
Seth Govindji Raoji Ayurved Mahavidyalay |
| Address |
Opd no 2,3,10 Kayachikitsa Department Seth Sakharam Nemchand Jain Ayurveda Rugnalaya 118/119 shukrawar peth near juni faujdar chawdi Solapur MAHARASHTRA 413002 India
Solapur
MAHARASHTRA
413002
India |
| Phone |
9834325038 |
| Fax |
|
| Email |
pratik.runwal@pg.sgrayurved.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Santosh I Swami |
| Designation |
Associate Professor Kayachikitsa Department |
| Affiliation |
Seth Govindji Raoji Ayurved Mahavidyalay Solapur |
| Address |
Opd no 2,3,10 Kayachikitsa Department Seth Sakharam Nemchand Jain Ayurveda Rugnalaya 118/119 shukrawar peth near juni faujdar chawdi Solapur MAHARASHTRA 413002 India
Solapur
MAHARASHTRA
413002
India |
| Phone |
9422957234 |
| Fax |
|
| Email |
santosh.swami@sgrayurved.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pratik Narendra Runwal |
| Designation |
PG Scholar |
| Affiliation |
Seth Govindji Raoji Ayurved Mahavidyalay Solapur |
| Address |
Opd no 2,3,10 kayachikitsa department Seth Sakharam Nemchand Jain Ayurveda Rugnalaya 118/119 shukrawar peth near juni faujdar chawdi Solapur MAHARASHTRA 413002 India
Solapur
MAHARASHTRA
413002
India |
| Phone |
9834325038 |
| Fax |
|
| Email |
pratik.runwal@pg.sgrayurved.edu.in |
|
|
Source of Monetary or Material Support
|
| Seth Sakharam Nemchand Jain Ayurveda Rugnalaya 118/119 shukrawar peth near juni faujdar chawdi Solapur MAHARASHTRA 413002 India |
|
|
Primary Sponsor
|
| Name |
Dr Pratik N Runwal |
| Address |
Seth Sakharam Nemchand Jain Ayurveda Rugnalaya 118/119 shukrawar peth near juni faujdar chawdi Solapur MAHARASHTRA 413002 India |
| 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 Pratik N Runwal |
Seth Sakharam Nemchand Jain Ayurved Rugnalaya Solapur |
Kayachikitsa Department Opd no2 Opd no3
Solapur
MAHARASHTRA |
9834325038
pratik.runwal@pg.sgrayurved.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Seth Govindji Raoji Ayurveda Mahavidyalaya Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K70-K77||Diseases of liver. Ayurveda Condition: KAMALA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Dhatrilohayog, Reference: yogratnakar, Route: Oral, Dosage Form: , Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -madhu sharkara), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Triphaladi Yoga, Reference: Charak Samhita, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Madhu Ghrut), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients Having Lakshanas of Bahupitta Kamala
2.Patients having either raised Sr Bilirubin .
3.Patient willing to give voluntary informed consent for the study.
4.Patients in the age group of 18 to 60 years.
5.Patients of either sex.
6.Participants of one or all altered liver function test will be selected. |
|
| ExclusionCriteria |
| Details |
1.Patients with Obstructive Jaundice
2.Patients with Sr. Bilirubin (Total) more than 10mg/dl
3.Patients with Hemolytic Jaundice
4.Patients diagnosed with Liver cirrhosis, Hepatic Encephalopathy.
5.Age less than 18 years and more than 60 years
6.Pregnant women and lactating mothers.
7.The patient suffering Uncontrolled Diabetes Mellitus, Hypertension.
8.The patient having serious Cardiac disorders like MI, Cardiac failure. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To study the efficacy of Triphaladi yoga in Bahupitta Kamala (Hepatocellular
jaundice). |
30Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To study the safety of Triphaladi yoga and Dhatri loha yoga in Bahupitta Kamala (Hepatocellular jaundice).
2.To study Bahupitta Kamala in detail according to Ayurveda.
3.To study Hepatocellular jaundice in detail. |
30Days |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
29/12/2024 |
| 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 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
|
Hepatocellular jaundice is a grave illness that arises from liver ailments. Hepatocellular jaundice be caused by a wide range of factors, including viral hepatitis drugs or environmental toxicity,alcoholism, medication toxicity, obesity, and pregnancy. However, alcoholic hepatitis and viral hepatitis are the two main issues in India.Modern medical science has symptomatic specific treatment for this disease,In Ayurvedic text treatment of kamala is given very well.Kamalatuvirechaa.As keep in mind the vitiation of pitta dosha Nitya virechana and shaman chikitsa are very important also the fecal route is considered as the important route of bile and biliary products ayurveda medication helps in enterohepatic circulation of bilirubin. Triphaladi yoga has Amalaki, Haritaki,Bibhitaki,Haridra,Daruharidra,Katuka,Loha which has properties of agnideepan,mruduvirechan along with pittahar properties.Dhatrilohayoga contains Aamalaki,Shunti,Haridra,Maricha,Pipali,Loha which has mrudu virechak,agnideepan along with Tridoshahar properties. Keep in view complications of Hepatocellular jaundice,limitation in treatment the present 30 days study has been designed to compare effect of Ayurveda intervention in a serious illness Bahupitta Kamala( Hepatocellular jaundice) |