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CTRI Number  CTRI/2023/04/051738 [Registered on: 18/04/2023] Trial Registered Prospectively
Last Modified On: 16/09/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Preventive
Screening 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of Nirgundi Churna & Trikatu Churna in Obesity 
Scientific Title of Study   A Comparative Study of Nirgundi Churna and Trikatu Churna in the Management of Sthaulya w.s.r to Obesity 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prof Dr Arun kumar das 
Designation  Principal 
Affiliation  Government ayurvedic medical college ,tulsinagar, balangir ,odisha  
Address  Government ayurvedic medical college ,tulsinagar, balangir ,odisha

Balangir
ORISSA
767001
India 
Phone  9861229623  
Fax    
Email  dasarun1969@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Prof Dr Arun kumar Das 
Designation  Principal 
Affiliation  Government Ayurvedic College and Hospital 
Address  Government Ayurvedic College and Hospital,Tulsi Nagar,Balangir,Odisha

Balangir
ORISSA
767001
India 
Phone  9861229623  
Fax    
Email  dasarun1969@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Vishal Agarwal 
Designation  Associate Professor 
Affiliation  Rohilkhand Ayurvedic Medical College and Hospital 
Address  155,Shivpuri,Nainital Road,Opposite M.B Inter College ,Bareilly ,Uttar Pradesh
Sector 7,Ramganga Nagar Yojana,BIU Campus ,Dohra Road,Bareilly
Bareilly
UTTAR PRADESH
243122
India 
Phone  9412822332  
Fax    
Email  drvishalagarwal888@gmail.com  
 
Source of Monetary or Material Support  
Rohilkhand Ayurvedic Medical College & Hospital,Bareilly,Uttar Pradesh 
 
Primary Sponsor  
Name  Dr Vishal Agarwal 
Address  155,Shivpuri,Nainital Road,Opposite M.B Inter college,Bareilly,Uttar Pradesh 
Type of Sponsor  Other [Self Funding] 
 
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 
Dr Rakesh Kumar Tewari  Rohilkhanda ayurvedic medical college and hospital bareilly  OPD of kayachitsa, ground floor,ROOM NO.11
Bareilly
UTTAR PRADESH 
8755922339

ramchdean@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethical Committee Rohilkhand Ayurvedic Medical College and Hospital,Bareilly,Uttar Pradesh  Approved 
Institutional Ethics Committee Government Ayurvedic College & Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E669||Obesity, unspecified. Ayurveda Condition: MEDOROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: NIRGUNDI CHURNA, Reference: KAIDEV NIGHANTU, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -LUKEWARM WATER), Additional Information: -
2Comparator ArmDrugClassical(1) Medicine Name: TRIKATU CHURNA, Reference: SARANGDHAR SAMHITA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -LUKEWARM WATER), Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Patient at least fulfilling 2 of following 3
criteria
1. Subject with bmi more than 25 to 40.
2. Sthaulya diagnosed according to sign & symptoms
as per classical text.
3. Sthaulya patient without any systemic disorder.
 
 
ExclusionCriteria 
Details  Patient at least fulfilling 3 of following 5
criteria
1. History of any systemic illness.
2. Obesity caused by hormonal imbalance
3. Any kind of skin disease depends on steroidal drugs.
4. Pregnant and lactacting mother.
5. Age less than 18 years and more than 50 years.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Subjective parameters like
1.aalasya
2.alpabala
3 nidraadhikya
objective parametes like
1.BMI
2.Weight
3.Reduction in hip waist ratio
 
90 days 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in the objective criteria :
• Weight and BMI reduction
• Reduction in abdominal circumference
• Reduction in Waist circumference .
Subjective criteria :
• Alpabala
• Nidraadhikya
• Atipipasa
• Daurgandhya
• Snigdhata
• Gatrasaad will be reduced
 
90 DAYS 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   21/04/2023 
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="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NONE 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
Obesity is a leading preventable cause for death worldwide with increasing rates in adults and children. Globally more than 7 billion people are overweight. In 2015, 600 million adults and100 million children were obese in 195 countries. Authorities view it as one of the most serious public health problems in 21st century.Obesity is regarded as Medoroga a disorder of Medodhathu-adiopse tissue and fat metabolism. There are health issues associated like cardiovascular diseases, type 2 diabetes, musculoskeletal disorders, cancer of endometrium, cervix and colon, infertility, gallstones. Overweight refers to an excessive amount of body weight that includes muscles, bone, fat and water or when a person weighs more than what is considered to be healthy for his age and height.Medoroga is classified under Santharpanajanya Vyadhi and Sthoulya as a KaphajaNanatmaja vyadhi.Acharya Charaka and Vagbhata have mentioned “karshyamevavaramsthoulyamna hi sthoolasyabheshajam” implying Atisthulas are more liable to beat health risk than Atikrusha. Sthoulya is primarily Santharpanajanya Vyadhi so Chikitsa aims towards Apatarpanaupakramai.e; Langhana, Pachana, Deepana and Shodhana.Sthoulya has bad prognosis if not duly managed as it can cause death due to its many fold complications.Nidana Sevana leads to impaired Dhatwagni thus causing accumulation of Medas in excess and which later leads to Sthoulya.The treatment of Obesity in an initial stage, correction of Agni has itsimportance. Vata and Kapha being the main components of vitiation in Medoroga, AgniSandhookshana is primarily focused. The main treatment for Obesity cannot be dieting andexercise. Diet program may produce weight loss in short term, but maintaining the weight loss isfrequently difficult and often require making exercise and a low calory diet as a permanent part of a person’s lifestyle and the success rates ranges from 2 to 20%. The medicines used in Obesity (Rimonabant, sibutramine, orlistat) affects long term and complication of these are very common. Its uses are associated with high rates of Gastro Enteric side effects4,5. So it is better to adopt safe and effective treatment measures to prevent Obesity and Overweight by applying principles of Ayurveda.Keeping all the points of samprapti a sincere attempt has been made to check all the pathological factors in Medoroga. Considering the above points the clinical trial will be aimed to come outwith the help of effective formulations i.e; nirgundi churna(ref kaidev nighantu) composition nirgundi patra churna and trikatu churna (ref sharangdhar samhita) composition sunthi 1 pat pippali 1 pat and marich 1 part.
 a comparative study of nirgundi churna and trikatu churna in the management of sthaulya w.s.r to obesity.

 
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