FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/08/073018 [Registered on: 28/08/2024] Trial Registered Prospectively
Last Modified On: 27/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Diagnostic
Preventive 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of Phaltrikadi Kwatha and Vasadi Kashaya in Jaundice 
Scientific Title of Study   A comparative clinical study to evaluate the efficacy of Phalatrikadi Kwatha and Vasadi Kashaya in management of Bahupitta Kamala 
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 Shruti Suryakant Shelke 
Designation  PG Scholar Kayachikitsa 
Affiliation  MAMs Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune  
Address  O.P.D. NO 2 Kayachikitsa Department Ground Floor Saneguruji Arogya Kendra Malwadi Hadapsar Pune

Pune
MAHARASHTRA
411028
India 
Phone  7741975329  
Fax    
Email  shrutishelke007@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sachinkumar Patil  
Designation  Head of Department ,Department of Kayachikitsa 
Affiliation  MAMs Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune  
Address  O.P.D. NO 2 Kayachikitsa Department Ground Floor Saneguruji Arogya Kendra Malwadi Hadapsar Pune

Pune
MAHARASHTRA
411028
India 
Phone  9822603608  
Fax    
Email  drsachinkumarpatil@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Shruti Suryakant Shelke 
Designation  PG Scholar Kayachikitsa 
Affiliation  MAMs Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune  
Address  O.P.D. NO 2 Kayachikitsa Department Ground Floor Saneguruji Arogya Kendra Malwadi Hadapsar Pune

Pune
MAHARASHTRA
411028
India 
Phone  7741975329  
Fax    
Email  shrutishelke007@gmail.com  
 
Source of Monetary or Material Support  
MAMS Sumatibhai Shah Ayurved College O.P.D.NO 2 Kayachikitsa Department Ground Floor Sane guruji Arogya Kendra Hadapsar Pune-411028 maharashtra India 
 
Primary Sponsor  
Name  Dr Shruti Suryakant Shelke 
Address  O.P.D.NO 2 Kayachikitsa Department Ground Floor Sane Guruji Arogya Kendra Malwadi Hadapsar Pune-411028 Maharashtra India 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shruti Suryakant Shelke  Saneguruji Arogya Kendra Malwadi Hadapsar Pune 411028  O.P.D.NO 2 Kayachikitsa Department ground floor Sane Guruji Arogya Kendra malwadi hadapsar Pune
Pune
MAHARASHTRA 		 7741975329

shrutishelke007@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee MAMS Sumatibhai Shah Ayurved Mahavidyalaya And Sane Guruji Arogya Kendra  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K768||Other specified diseases of liver. Ayurveda Condition: KAMALA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Phaltrikadi Kwatha, Reference: Bhaishajya Ratnawali, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Madhyabhakta, Duration: 6 Weeks, anupAna/sahapAna: No, Additional Information:
(2) Medicine Name: Phaltrikadi Kwatha, Reference: Bhaishajya Ratnawali, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Madhyabhakta, Duration: 6 Weeks, anupAna/sahapAna: No, Additional Information:
2Comparator ArmDrugClassical(1) Medicine Name: Vasadi Kashaya, Reference: Bhaishajya Ratnawali, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Madhyabhakta, Duration: 6 Weeks, anupAna/sahapAna: No, Additional Information:
(2) Medicine Name: Vasadi Kashaya, Reference: Bhaishajya Ratnawali, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Madhyabhakta, Duration: 6 Weeks, anupAna/sahapAna: No, Additional Information:
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.
Age limit is from 18 to 60 years irrespective of Gender, Occupation, Religion and Economical condition.
2.
Patients having raised serum bilirubin 1.5-15 mg/dl
3.
Having signs and symptoms of Bahupitta Kamala
1.Haridra Netra
2.Rakta peet mutrata
3..Daha
4.Haridra Twak
5.Avipaka
6.Dourbalya
7.Aruchi
8.Anutsaha 
 
ExclusionCriteria 
Details  1.
Known cases of HIV infection, Malignancy
2.
Patients in hepatic encephalopathy.
3.
Serum bilirubin more than 15 mg/dl
4.
Pregnant & lactating mother
5.
Psychotic patients
6.
Congenital Causes -Gilbert’s Syndrome
7.
Drug induced hyper bilirubinaemia, Liver abscess 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
LFTs
To compare the efficacy of Phalatrikadi Kwatha and Vasadi Kashaya in Bahupitta Kamala 		 At base line ,15th day ,30th day,45th day 
 
Secondary Outcome  
Outcome  TimePoints 
To Observe adverse effects of Phalatrikadi Kwatha and Vasadi Kashaya   At base line ,15th day ,30th day,45th day 
 
Target Sample Size   Total Sample Size="66"
Sample Size from India="66" 
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 3 
Date of First Enrollment (India)   08/09/2024 
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  
Infections, drugs, alcohol and other dietary and environmental toxins induce structural and functional damage and predispose the liver to vast array of disorders. Bahupitta Kamala.
i.e. Hyperbilirubinemia is a very common disorder found now a days.
In this disease aversion to all desires i.e. food ,exercise ,work, etc. occurs . Bahupitta Kamala is a disease of Raktavaha strotasa, which is given in Ayurvedic texts. In Bahupitta Kamala, the Pitta Dosha of body increases due to Ushna and Tiksna Guna of Pitta. Kamala is mentioned in Ayurvedic texts can be compared with Jaundice 
Jaundice is a medical condition characterized by the yellowing of the skin and eyes due to elevated levels of bilirubin in the bloodstream. It can be caused by various factors such as liver disease, hepatitis, alcohol abuse, certain medications, or other underlying health conditions. While conventional medical treatments for jaundice primarily focus on addressing the underlying cause and providing supportive care, traditional systems of medicine, such as Ayurveda, have been explored for their potential efficacy in managing the condition.
The key ingredients in Phalatrikadi Kwatha and Vasadi Kashaya are believed to possess hepatoprotective, antioxidant, anti-inflammatory, and immunomodulatory properties, which could potentially aid in the treatment of jaundice.
While Phalatrikadi Kwatha and Vasadi Kashaya shows promise in traditional use and some preclinical studies, it is essential to note that scientific evidence regarding its efficacy in jaundice is limited. Most of the available studies are preclinical or based on traditional knowledge, and clinical trials are required to establish its effectiveness and safety in the management of jaundice
conducting a comparative study of the efficacy of Phalatrikadi Kwatha and Vasadi Kashaya in Bahupitta Kamala is important to provide scientific evidence, evaluate safety, and support their integration into evidence-based healthcare practices. This research can contribute to the overall understanding and utilization of Ayurvedic formulations for liver disorders, benefiting patients and healthcare providers alike.
Hence Selected this topic for Study
 
Close