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CTRI Number  CTRI/2025/11/097667 [Registered on: 18/11/2025] Trial Registered Prospectively
Last Modified On: 27/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Other 
Public Title of Study   Effect of Guduchi musta churn in childhood sthaulya. 
Scientific Title of Study   Efficacy of Guduchi Musta churn as an add-on medicine to Lifestyle modification in childhood sthaulya (overweight) -A comparative clinical trial 
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 Anjali kale 
Designation  1st year PG scholar Kaumarbhritya 
Affiliation  Dr.G D Pol foundation YMT ayurvedic medical college kharghar. 
Address  OPD No.18 and Room 207 ,second floor ,Department of Kaumarbhritya ,Dr.G D Pol foundation YMT ayurvedic medical college kharghar. Navi mumbai,sector 4, Raighar .

Raigarh
MAHARASHTRA
410210
India 
Phone  8788315840  
Fax    
Email  kaleanjali684@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sandeep Rajput 
Designation  HOD and Profesor of Kaumarbhritya depatment YMT ayurvedic college 
Affiliation  Dr.G D Pol foundation YMT ayurvedic medical college kharghar. 
Address  OPD No.18 and Room 207 ,second floor ,Department of Kaumarbhritya ,Dr.G D Pol foundation YMT ayurvedic medical college kharghar. Navi mumbai,sector 4 Raighar.

Raigarh
MAHARASHTRA
410210
India 
Phone  9167133548  
Fax    
Email  dr.rajputsandeep@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sandeep Rajput 
Designation  HOD and Profesor of Kaumarbhritya depatment YMT ayurvedic college 
Affiliation  Dr.G D Pol foundation YMT ayurvedic medical college kharghar. 
Address  OPD No.18 and Room 207 ,second floor ,Department of Kaumarbhritya ,Dr.G D Pol foundation YMT ayurvedic medical college kharghar. Navi mumbai,sector 4 Raighar.

Raigarh
MAHARASHTRA
410210
India 
Phone  9167133548  
Fax    
Email  dr.rajputsandeep@gmail.com  
 
Source of Monetary or Material Support  
Dr.G D Pol Foundation ,YMT Ayurvedic Medical College , ,Kharghar ,Navi mumbai ,Maharashtra ,410210 ,India 
 
Primary Sponsor  
Name  Dr. Anjali Kale 
Address  Dr. G D Pol foundation YMT ayyurvedic medical college kharghar. sector 4,Navi mumbai-410210 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Dr Sandeep Rajput  Dr. G D Pol foundation YMT ayyurvedic medical college kharghar. sector 4,Navi mumbai-410210 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Anjali Kale  Dr G D Pol Foundation YMT Ayurvedic Medical College   OPD No.18 and Room 207 ,second floor ,Department of Kaumarbhritya ,Dr.G D Pol foundation YMT ayurvedic medical college kharghar. Navi mumbai,sector 4,Maharashtra ,410210
Raigarh
MAHARASHTRA 
8788315840

kaleanjali684@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee ,Dr G D Pol Foundation ,YMT Ayurvedic medical college and charitable hospital,Kharghar , Navi mumbai  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 ArmDrugClassical(1) Medicine Name: Guduchi Musta churna, Reference: Charak sutrasthan 21/22, Route: Oral, Dosage Form: Churna/ Powder, Dose: 0(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 8 Weeks, anupAna/sahapAna: Yes(details: -Koshna jala), Additional Information: -Dose will be calculated using Clarks formula as per weight of child
2Comparator ArmLifestyle--Dinacarya: yes, Ritucarya: , Acara Rasayana:, Other:, Pathya/Apathya:yes, Pathya:Green gram, Bengal gram, red gram, horse gram Leafy vegetables, brinjal, drumsticks, bottle gourd bitter gourd, radish, carrot, cucumber, ridge gourd, cabbage, ginger Daily physical exercise for min ½-1 h such as Suryanamskar, brisk walking, cycling, skipping, swimming, and playing outdoor games. etc, Apathya:Fine powder of wheat, refined wheat flour, rice ,Egg, chicken, mutton, pork ,Divaswapna (day sleep)/excessive sleeping, sleeping immediately after meals ,etc
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  16.00 Year(s)
Gender  Both 
Details  Children of either sex age between 10 to 16 years
Children having percentile comparing height and weight between 85th to 95th
according to CDC growth chart. 
 
ExclusionCriteria 
Details  Any pre diagnosed hormonal disorders like Hypothyroidism Cushing syndrome
diabetes mellitus etc.
Children’s with other co-morbidity condition such as HIV TB etc.
K/C/O immuno compromised disease and malignancy etc. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evaluate the efficacy of Guduchi Musta Churna in reducing BMI in patients with Sthaulya when administered along with lifestyle modification.  0 2 4 6 8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the effect of Guduchi Musta Churna on the anthropometric measures  0 2 4 6 8 weeks 
To compare the improvement in sign and symptoms of Sthaulya  0 2 4 6 8 weeks 
To change dietary and sedentary lifestyle  0 2 4 6 8 weeks 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   01/01/2026 
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  
Childhood overweight is one of the major problem with increasing prevalence. Excessive body weight is associated with various diseases and potential cause for various social and psychological problems. It is a chronic metabolic condition characterized by abnormal or excessive fat accumulation arising from an imbalance between energy intake and expenditure. Rapidly changing dietary habits & lifestyle have led to increasing prevalence of childhood overweight. Children having BMI percentile Between 85th - 95th are considered overweight. Childhood overweight is considered as one of the most serious health issue worldwide.  As per the modern science the pathophysiology of overweight primarily involves an imbalance between energy intake and expenditure, leading to excess fat deposition in adipose tissue. Adipocyte hypertrophy and hyperplasia cause altered secretion of adipokines which regulate appetite and metabolism. elevated free fatty acids and pro-inflammatory cytokines induce insulin resistance, contributing to metabolic syndrome. Genetic susceptibility also plays key roles in disease progression. Monogenic forms of obesity have also been identified, including MC4R deficiency ,associated with early onset obesity and food seeking behavior. Epigenetics environmental modification of gene may have a role in the development of obesity, especially during fetal and early life.According to Ayurveda, as described by Acharya charka sthaulya is one of the eight disgraceful Persons Difficult to cure designated as Ashtanindita Purush. Sthaulya is one of them. Sthaulya is defined as persons who has excessive accumulation of meda and mansdhatu especially over stana, uder, nitamb. It is one of the Santarpanottha Vikaras and & Shleshma Nanatmaja Vikaras. Etiopathogenosis, prognosis & management of overweight is very similar to Medorog. sthaulya is mostly found in people with predominant kapha type constitution (kapha prakruti) Ayurvedic formulations, Panchkarma therapy, Yogasana, pranayama, along with pathya apathhya (dietary & Lifestyle modification) are explained under treatment of Sthaulya. Guduchi and Musta are Kaph Shyamak, agnivrudhikar. The purpose of this research is to the study the effect of Guduchi Musta Churna in Medoroga in comparison with lifestyle Modification. As per Ayurveda, in Santarpanottha Vikaras Apatarpana is the Prime therapy to treat Sthaulya in wich three main treatments are mentioned that are swedana, langhana and rukshana this treatment reduces sthaulya effectively. These properties are present in Guduchi and musta hence this drugs selected for the study. Ayurvedic Formulation can effectively manage childhood ovenereight without causing any side effects.
 
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