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CTRI Number  CTRI/2023/11/060152 [Registered on: 22/11/2023] Trial Registered Prospectively
Last Modified On: 02/11/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Diagnostic 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To Study the effectiveness between Bilvadi Panchamoola Churna and Guduchyadi Churna in the management of Sthaulya [Overweight] in children of age group 8 to 15 years 
Scientific Title of Study   A Randomized Controlled Clinical Trial to evaluate the efficacy of Bilvadi Panchamoola Churna and Guduchyadi Churna in the management of Sthaulya [Overweight] in children of age group 8 to 15 year 
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 Pooja Mahadev Mukadam 
Designation  P.G. Scholar 1st year 
Affiliation  PDEAS College of Ayurved and Research Centre Nigdi Pune 
Address  PDEAS College of Ayurved and Research Centre Balrog Department second floor Nigdi sector 25 Pune

Pune
MAHARASHTRA
411044
India 
Phone  9172900221  
Fax    
Email  poojamukadam94@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Madhavi Deodas 
Designation  Professor and HOD 
Affiliation  PDEAS College of Ayurved and Research Centre Nigdi Pune 
Address  PDEAS College of Ayurved and Research Centre Balrog Department second floor Nigdi sector 25 Pune

Pune
MAHARASHTRA
411044
India 
Phone  9423010818  
Fax    
Email  drdeodasms@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Madhavi Deodas 
Designation  Professor and HOD 
Affiliation  PDEAS College of Ayurved and Research Centre Nigdi Pune 
Address  PDEAS College of Ayurved and Research Centre Balrog Department second floor Nigdi sector 25 Pune

Pune
MAHARASHTRA
411044
India 
Phone  9423010818  
Fax    
Email  drdeodasms@gmail.com  
 
Source of Monetary or Material Support  
PDEAS College of Ayurved and Research Centre Nigdi Pune 
 
Primary Sponsor  
Name  Dr Pooja Mahadev Mukadam 
Address  PDEAS College of Ayurved and Research Centre Sector 25 Nigdi Pune 
Type of Sponsor  Other [] 
 
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 
DrPooja Mahadev Mukadam  Ayurved Rugnalaya And Sterling Multispeciality Hospital  Balrog Department OPD No 118 Ayurved Rugnalaya And Sterling Multispeciality Hospital Sector 27 Nigdi Pune 411044
Pune
MAHARASHTRA 
9172900221

poojamukadam94@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee  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
1Comparator ArmDrugClassical(1) Medicine Name: Guduchyadi Churna, Reference: Yogratnakar Medorog 17, Route: Oral, Dosage Form: Churna/ Powder, Dose: 100(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -Madhu), Additional Information: -
2Intervention ArmDrugClassical(1) Medicine Name: Bilvadi Panchamool Churna, Reference: charak sutra 21/24, Route: Oral, Dosage Form: Churna/ Powder, Dose: 100(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -Madhu), Additional Information: -
 
Inclusion Criteria  
Age From  8.00 Year(s)
Age To  15.00 Year(s)
Gender  Both 
Details  1. Patients having minimum 4 clinical features of sthaulya as kshudhadhikya, shariragaurava, swedabadh, daurgandha, dourbalya.
2. Age group between 8 to 15 years irrespective of sex and socio economic status
3. Patients having BMI 25 to 29.9
4. Weight more than 85th percentile(i.e.overweight) 
 
ExclusionCriteria 
Details  1. Overweight due to metabolic disorder (Hypothyroidism,
Endocrine disorders).
2. Systemic disorders (Congenital Heart Defects, Acute Infectivve Hepatitis and major renal diseases)
3. Known case of inborn error of metabolism.
 
 
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 
To study the efficacy of Bilvadi Panchamool churna on body
weight in the management of Sthaulya for 60 days. 
60 days study
follow up on 15th 30th 45th 60th day. 
 
Secondary Outcome  
Outcome  TimePoints 
To observe the adverse effect if any for 60 days.  60 days study follow up on 15th 30th 45th 60th day. 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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/ Phase 3 
Date of First Enrollment (India)   01/12/2023 
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   Ayurveda have described Sthaulya in Medoroga and Rasapradoshaja vikara . Acharya Kashyapa has considered Sthaulya as one of the aprashasta  sharira during explaining the anthropology. 
Acharya Sushruta has considered it as Daruna vyadhi and has established relation of Sthaulya and karshya with quality and production n of rasa dhatu. Bhela Samhita has described it as Medovyapattijanya  Roga . Acharya Charaka has described Sthaulya roga among the astaunindita purusha, Santarapanajanya Vikara, Kapha nanatmaja diseases and Samsodhana yogya vyadhi. Childhood obesity is a known pioneer to obesity and other noncommunicable diseases in later life. Environmental and genetic c factors, lifestyle preferences and culture plays a major role in the increasing prevalence of childhood obesity. WHO defines childhood obesity as one of major public health problem of 21st century  . Obesity means excess accumulation of fat in body . In childhood period if child is significantly overweight for his or her age and height, he/ she suffers from childhood obesity. The estimation n of weight can be done with the help of BMI (body mass index). Weight is earliest parameter used for definition of obesity. After covid pandemic overweight is a serious issue we are finding in children. Obesity may hamper physical and mental growth of children. Children suffer from psychological issues. To overcome all these things it’s need to study on Sthaulya in children. In Modern medical science, drugs are used for obesity which reduces absorption of food or causes suppression of appetite. If we go through Ayurvedic formula which are used in Sthaulya, Guggulu is found to be main ingredient in most of them. But it is also seen that Guggulu is not suitable to all in context to Prakriti, Desha, Kala and age. So there is a necessity to find out substitute. While describing the treatment of Sthaulya, Acharya Charaka emphasized on the use of Ruksha, Ushna and mainly Kapha Vatashamana drugs like Bilvadi Panchmool and use of Madhu for the management of Sthaulya. In Bilvadi Panchmool Churna, there is combination  of five drugs i.e. Bilva. Agnimanth, Gambhari, Patla and Shyonak. Hence the drug has been selected in the management of sthaulya.
 
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