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CTRI Number  CTRI/2025/01/079536 [Registered on: 27/01/2025] Trial Registered Prospectively
Last Modified On: 26/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Preventive 
Study Design  Other 
Public Title of Study   Effect of Patoladi Kwatha and Phalatrikadi Kwatha in treatment of Kamala 
Scientific Title of Study   A Comparative Clinical Study to evaluate the efficacy of Patoladi Kwatha and Phalatrikadi Kwatha 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 Vijaya Pandurang Dhumal 
Designation  M.D.(Kayachikitsa) Scholar 
Affiliation  MAMs Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune 
Address  O.P.D. NO 2 Kayachikitsa Department Ground Floor Sane Guruji Arogya Kendra Malwadi Hadapsar Pune
O.P.D No.2 Kayachikitsa Department Ground Floor Sane Guruji Arogya Kendra Malwadi Hadapsar Pune
Pune
MAHARASHTRA
411028
India 
Phone  7276586899  
Fax    
Email  dhumalvijaya13@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
O.P.D No 2 Kayachikitsa Department Ground Floor Saneguruji Arogya Kendra Malwadi Hadapsar Pune

MAHARASHTRA
411028
India 
Phone  9822603608  
Fax    
Email  drsachinkumarpatil@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Vijaya Pandurang Dhumal 
Designation  M.D.(Kayachikitsa) Scholar 
Affiliation  MAMs Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune 
Address  O.P.D NO 2 Kayachikitsa Department Ground Floor Sane Guruji Arogya Kendra Malwadi Hadapsar Pune
O.P.D NO 2 Kayachikitsa Department Ground Floor Sane Guruji Arogya Kendra Malwadi Hadapsar Pune

MAHARASHTRA
411028
India 
Phone  7276586899  
Fax    
Email  dhumalvijaya13@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. Vijaya Pandurang Dhumal 
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 Vijaya Pandurang Dhumal  Sane guruji Arogya Kendra Malwadi Hadapsar Pune 411028  O.P.D NO 2 Kayachikitsa Department ground floor Sane Guruji Arogya Kendra Malwadi Hadapsar Pune
Pune
MAHARASHTRA 		 7276586899

dhumalvijaya13@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:K769||Liver disease, unspecified. Ayurveda Condition: KAMALA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Patoladi Kwatha, Reference: Ashtanga Hrudaya, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Madhyabhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -Koshna jal), Additional Information: -
2Comparator ArmDrugClassical(1) Medicine Name: Phalatrikadi Kwatha, Reference: Sharangdhar, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Madhyabhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -Koshna jal), Additional Information: -
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Age limit is from 19 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
with cardinal symptoms :-
1. Haridra Netra
2. Haridra Twaka
3. Rakta peeta mutrata
associated symptoms:-
1. Daha
2. Dourbalya
3. Aruchi
4. Anutsaha
5. Avipaka 
 
ExclusionCriteria 
Details  1. Known cases of HIV infection, Malignancy
2. Patients in hepatic encephalopathy.
3. Pregnant & lactating mother
4. Psychotic patients
5. Congenital Causes -Gilbert’s Syndrome
6. Drug induced hyper bilirubinaemia. 
 
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 Patoladi Kwatha and Phalatrikadi Kwatha in Bahupitta Kamala 		 Baseline 15th day,30th day,45th day 
 
Secondary Outcome  
Outcome  TimePoints 
To observe adverse effects of Patoladi Kwatha and Phalatrikadi Kwatha  At base line,15th day,30th day,45th day 
 
Target Sample Size   Total Sample Size="72"
Sample Size from India="72" 
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)   06/02/2025 
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  
Jaundice is a condition in which yellowish discoloration appears on the skin, in mucous
membrane and sclera due to elevated levels of bilirubin in the bloodstream. Jaundice
frequently indicate problem with liver functioning.
At Present scenario, industrialization has brought a lot of changes in our lifestyle and
especially in food eating habits. Most of the people have become used to spicy fast-food day
by day. This changes in lifestyle has invited various diseases. Also there is increased
prevalence due to increased population living in congested area, poor sanitation and
consumption of unhygienic food and polluted water, etc.
Modern science has limitations in treating Kamala Vyadhi (jaundice) but Ayurvedic
literature clearly explained pathology and treatment of Kamala Vyadhi which shows the
specificity of Ayurveda.
Modern system of medicine is basically designed to alleviate the symptoms, on other
hand Ayurveda based upon upon mind, body soul theory and make use of natural products
with fewer side effects and is targeted to eliminate root cause by establishing balance in body
physiology.

Patoladi Kwatha 4 is an Ayurvedic herbal formulation that is used in Kamala. The
rationale behind its potential efficacy lies in the specific properties of the herbs used in its
preparation and their traditional use in Ayurveda for liver-related disorders.
The key ingredients in Patoladi Kwatha include :-
Trichosanthes dioicia
(Patola)
Picrorhiza kurroa (Katurohini)
Tinospora cordifolia (Guduchi)
Santalum album (Chandana)
Marsdenia tenacissima (Murva)
Cissampelos parieria (Patha).
These herbs are believed to possess hepatoprotective, antioxidant, anti-inflammatory, and
immunomodulatory properties, which could potentially aid in the treatment of jaundice.5
 
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