| 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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E663||Overweight. Ayurveda Condition: MEDOROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (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 | | 2 | Comparator Arm | Lifestyle | - | - | 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. |