| 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
|
|
|
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
|
|
|
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 | Comparator Arm | Drug | Classical | | (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: - | | 2 | Intervention Arm | Drug | Classical | | (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. |