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CTRI Number  CTRI/2024/06/069078 [Registered on: 18/06/2024] Trial Registered Prospectively
Last Modified On: 17/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Effect of internal administration of triphaladhyam taila formulation followed by therapeutic purgation with triphala powder in reducing the body mass index of patients who are overweight 
Scientific Title of Study   Effect of shodhananga snehapaana with triphaladhyam taila followed by virechana with triphala choorna in overweight 
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.Pallavy Jayakumar 
Designation  PG scholar 
Affiliation  Government ayurveda college ,Thiruvananthapuram 
Address  Department of panchakarma op no:1 Government ayurveda panchakarma hospital Poojappura Thiruvananthapuram
Aswathy Alathara Sreekaryam PO Trivandrum
Thiruvananthapuram
KERALA
695001
India 
Phone  8547011918  
Fax    
Email  pallusaroja@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr.Pallavy Jayakumar 
Designation  Pg scholar 
Affiliation  Government ayurveda college ,Thiruvananthapuram 
Address  Department of panchakarma op no:1 Government ayurveda panchakarma hospital Thiruvananthapuram
Aswathy alathara sreekaryam PO Trivandrum
Thiruvananthapuram
KERALA
695001
India 
Phone  8547011918  
Fax    
Email  pallusaroja@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr.Ambili Krishna 
Designation  Assistant Professor 
Affiliation  Government ayurveda college ,Thiruvananthapuram 
Address  Department of panchakarma op no:1 Government Ayurveda panchakarma hospital Thiruvananthapuram
Department of panchakarma op no:1 Government Ayurveda panchakarma hospital Thiruvananthapuram
Thiruvananthapuram
KERALA
695001
India 
Phone  9847827220  
Fax    
Email  dr.ambilikrishna@gmail.com  
 
Source of Monetary or Material Support  
Government ayurveda medical college and hospital Pulimood junction Thiruvananthapuram 695001 
 
Primary Sponsor  
Name  PALLAVY JAYAKUMAR 
Address  Government ayurveda medical college and hospital Pulimood junction Thiruvananthapuram 695001 
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 
DrPallavy Jayakumar  Government ayurveda panchakarma hospital  Department of panchakarma op no:1
Thiruvananthapuram
KERALA 		 8547011918

pallusaroja@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE,GOVERNMENT AYURVEDA COLLEGE,THIRUVANANTHAPURAM,KERALA,INDIA  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E663||Overweight. Ayurveda Condition: MEDOROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-acCasnehaH, अच्छस्नेहः (Procedure Reference: Ashtanga hridaya sutrasthana 16th chapter, Procedure details: accha snehahapana or internal administration of triphaladhyam taila will be given till samyak snigdha lakshana. Then the patient is asked to take oil application followed by hot water bath for 3 days.It will be followed by virechana with triphala choorna for one day)
(1) Medicine Name: triphaladhyam taila, Reference: chakradutta sthoulya chikitsa, Route: Oral, Dosage Form: Taila, Dose: 50(ml), Frequency: od, Duration: 7 Days
2Intervention ArmProcedure-virecana-karma, विरेचन-कर्म (Procedure Reference: Ashtanga hridaya suthrasthana 18th chapter, Procedure details: triphala choorna will be given along with draksha swarasa anupana at morning 8 am on empty stomach)
(1) Medicine Name: triphala choorna, Reference: ashtanga hridaya suthrasthana 5th chapter, Route: Oral, Dosage Form: Churna/ Powder, Dose: 40(g), Frequency: od, Duration: 1 Days
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  BMI ranging from 25kg/m2 to 29.9kg/m2 
 
ExclusionCriteria 
Details  Patients on long term steroid treatment
Those who are suffering from severe hypertension,type 2 diabetes mellitus with evidence of renal,hepatic and cardiac involvement
Pregnant women and lactating mothers 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Reduction in BMI will be assessed  BMI will be assessed at the beginning of the study(0th day),after rukshana(6th day),after snehapana(13th day) and after virechana(17th day)  
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
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 3/ Phase 4 
Date of First Enrollment (India)   06/07/2024 
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  
Obesity and overweight are defined as abnormal or excessive fat accumulation that presents a risk
to health. A body mass index(BMI) over 25 is considered overweight and over 30 is obese. The
issue has grown to epidemic proportions,with over 4 million people dying each year as a result of
being overweight or obese in 2021 according to the global burden of disease. In Ayurveda obesity
and overweight may be correlated to ‘sthoulya’. In obese and overweight persons, kapha dosha
and medho dhatu is said to be vitiated. They are indicated for taila snehapaana in classics.
Atisthoulya is a bahudosha condition which is indicated for shodhana. Triphaladhyam taila is a
yoga mentioned in Chakradatta sthoulya adhikaara which is indicated for paana also. Triphala
choorna has laxative as well as scraping effect on medo dhatu of our body. Objective of this
study is to evaluate the efficacy of triphaladhyam taila, administered continuously till samyak
snigdha lakshana followed by virechana with triphala choorna in managing overweight.
It will be an experimental type of study design, assessment will be done before and after the
treatment. Participants aged between 20-60 years registered in the IP department of Government
Ayurveda Panchakarma Hospital, Poojappura, Thiruvananthapuram satisfying the inclusion
criteria will be selected. The baseline data will be collected through questionnaire, subjective and
objective examination. After collecting baseline data, detailed history and examination will be
done using clinical case proforma.
A total of 20 participants will be selected by consecutive sampling. Rookshana will be done prior to
snehapaana with gandarvahastadi kashayam 48ml bd before food and vaishwanara choorna 6gm
with kashaya. Internal administration of triphalaadhyam taila will be done according to agni and
koshta of the participants. Snehapana will be stopped after attainment of samyak snigdha lakshanas
and then self abhyanga with panchaamla taila and ushnodaka snaana for 3 days will be advised.
After that virechana will be done with triphala choorna for 1 day. The participants will be assessed
for the objective variables like weight and BMI on the 0th day, before and after snehapaana and after
virechana . Depending upon the distribution of variables, it will be analysed using Wilcoxon’s signed
rank test or paired t test or ANOVA test

 
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