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CTRI Number  CTRI/2024/08/072799 [Registered on: 21/08/2024] Trial Registered Prospectively
Last Modified On: 20/08/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of Black rice / forbidden rice in Obesity. 
Scientific Title of Study   Efficacy of Black rice ( ORZYA SATIVA L INDICA) in Obesity : Open lable double arm exploratory randomized controlled 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 Madhavi Mahajan 
Designation  Professor 
Affiliation  Bharati Vidyapeeth college of ayurved and hospital pune 
Address  Bharati Vidyapeeth college of ayurved and hospital, Department of Kayachikitsa, OPD no 4, pune

Pune
MAHARASHTRA
411043
India 
Phone    
Fax    
Email  bhiruds@yahoo.o.in  
 
Details of Contact Person
Scientific Query  
Name  Dr D L Shinde 
Designation  H.O. D. and Professor 
Affiliation  Bharati Vidyapeeth college of Ayurved and hospital pune 
Address  Bharati Vidyapeeth college of ayurved and hospital, Department of Kayachikitsa, OPD no 4, pune

Pune
MAHARASHTRA
411043
India 
Phone  9890111954  
Fax    
Email  dshinde249@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr D L Shinde 
Designation  H.O. D. and Professor 
Affiliation  Bharati vidyapeeth college of ayurved and hospital pune 
Address  Bharati Vidyapeeth college of ayurved and hospital, Department of Kayachikitsa, OPD no 4, pune

Pune
MAHARASHTRA
411043
India 
Phone  9890111954  
Fax    
Email  dshinde249@gmail.com  
 
Source of Monetary or Material Support  
Bharati vidyapeeth college of ayurved and hospital Department of kayachitkisa, OPD no. 4 
 
Primary Sponsor  
Name  Bharati Vidyapeeth Deemed to be university  
Address  Bharati vidyapeeth Bhavan Lal bahadur shastri road, joshi wada, sadashiv peth, pune 411030 
Type of Sponsor  Research institution and hospital 
 
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 D L Shinde  Bharati Ayurved Hospital pune  Department of Kayachikitsa, OPD no. 4,
Pune
MAHARASHTRA 		 9890111954

Kayachikitsad123@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
BVDU Human Ethics committee  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
1Comparator ArmDrugOther than Classical(1) Medicine Name: White rice, Reference: NA, Route: Oral, Dosage Form: , Dose: 100(g), Frequency: od, Bhaishajya Kal: Sabhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: It is Ahara kalpna
2Intervention ArmDrugClassical(1) Medicine Name: Black rice , Reference: Krishnavrihi, Route: Oral, Dosage Form: , Dose: 100(g), Frequency: od, Bhaishajya Kal: Sabhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: It is Ahara kalpna
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Obese individuals showing symptoms of obesity, having BMI between ≥25.0 kg/m2 and ≤ 34.9 kg/m2), without or with controlled co-morbid conditions such as dyslipidemia, hypertension, and type 2 diabetes mellitus.
 
 
ExclusionCriteria 
Details  Individuals with known endocrinological disorders such as hyper/hypothyroidism, Poly Cystic Ovarian Syndrome (PCOS)
Major depressive or other severe psychiatric disorders
Drug-induced obesity
Individuals taking herbal drugs or nutritional supplements/multivitamin supplements within the past 30 days for weight loss
Pregnant and lactating females
Individuals taking Metformin or Insulin for Diabetes mellitus. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The primary outcome will be the 10% body weight reduction from baseline  90 days 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in body circumference, percentage of body fat, visceral fat

Improvement in fasting blood glucose and insulin level, Lipid profile (Total cholesterol, Triglycerides, LDL & HDL) Inflammatory marker (Hs-CRP), Oxidative stress markers ( MDA, SOD) along with Adipocytokines (leptin and adiponectin). 		 90 days 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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 
Date of First Enrollment (India)   05/09/2024 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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   The last few decades have seen a marked rise in obesity rates worldwide, despite numerous efforts at prevention and treatment. This has resulted in a substantial financial and health burden. Imbalanced nutritional value and uncontrolled eating lead to the development of obesity and poor self-esteem. Food grains such as brown rice have recently drawn the attention of many researchers away from synthetic treatments in favor of safe, natural solutions for obesity since they are readily available and reasonably priced. However, no such studies have been reported on the indigenous variety of black rice, ‘Krishnavrihi (Oryza sativa L indica). According to Sushruta (Sushruta saṃhita Sutrasthana 46/14), among the vrihi /rice the black variety, which is called Ká¹›iá¹£hṇavrihi, is the best. Krishnavrihi is kashaya in anurasa, reduces all three doshas, increases Agni, and enhances strength and virility. (Bhojana-kutuhala, Sri Raghunatha Suri.).It has has kleda meda vishoshan property.
Black rice (BR) has high nutritional value due to the presence of 18 amino acids, carotene, vitamin E, iron, zinc, and copper and high anthocyanin content (327.60 mg/100g). Epidemiological evidence reported that anthocyanins possess not only high antioxidant and anti-inflammatory activities but also improve metabolic complications associated with obesity. Black rice contains cyanidin-3-o-glucoside (C3G), which is known to act by directly interacting with PPARα to increase hepatic fatty acid oxidation and reduce fatty acid synthesis. These effects lead to reduced plasma and hepatic TG concentrations, with increased ketogenesis, improved NAFLD, glucose and insulin tolerance, and adiposity. Studies have demonstrated that black rice extract (BRE) (Heukmi) inhibited adipogenic differentiation in C3H10T1/2 multipotent stem cells.
Given the small number of studies on black rice originating from northeast India, the current study would therefore provide scientific proof for its health benefits.
The study is a dietary intervention trial; an open-label, double-arm exploratory clinical study of black rice to find out efficacy in obesity will be carried out. Obese patients visiting BVDU’s College of Ayurveda and Hospital will be recruited in the trial by following standard protocol. The study site will be the Dept. of Kayachikitsa of B.V.D.U.C.O.A. and Hospital, Pune.
 
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