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 |
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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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition:E669||Obesity, unspecified. Ayurveda Condition: MEDOROGAH, |
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Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Intervention Arm | Drug | Classical | | (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: - | 2 | Comparator Arm | Drug | Classical | | (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: - |
|
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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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