FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/07/070227 [Registered on: 09/07/2024] Trial Registered Prospectively
Last Modified On: 30/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   A clinical study to see the efficacy of bhunimbadi churna in prameha purvarupa with special reference to prediabetes. 
Scientific Title of Study   An open clinical study to evaluate the effect of BHUNIMBADI CHURNA in Prameha Purvarup with special reference to Prediabetes 
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 Deepika Suryawanshi 
Designation  MD Scholar 
Affiliation  R A PODAR AYURVEDIC MEDICAL COLLEGE WORLI MUMBAI 18 
Address  R A Podar Ayurvedic Medical College Worli Mumbai 18 kayachikitsa Department OPD Number 18

Mumbai
MAHARASHTRA
400018
India 
Phone  9901639770  
Fax    
Email  suryavamshideepika86@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Dilip Wange  
Designation  Associate Professor 
Affiliation  R A Podar ayurvedic medical College Worli mumbai 18 
Address  R A Podar Ayurvedic Medical College Worli Mumbai 18 kayachikitsa Department OPD Number 18

Mumbai
MAHARASHTRA
400018
India 
Phone  9892323677  
Fax    
Email  drdilip.wange@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Dilip Wange  
Designation  Associate Professor 
Affiliation  R A Podar ayurvedic medical College Worli mumbai 18 
Address  R A Podar Ayurvedic Medical College Worli Mumbai 18 kayachikitsa Department OPD Number 18

Mumbai
MAHARASHTRA
400018
India 
Phone  9892323677  
Fax    
Email  drdilip.wange@gmail.com  
 
Source of Monetary or Material Support  
R A Podar Ayurvedic Medical College Worli Mumbai 18 
 
Primary Sponsor  
Name  DR Deepika Suryawanshi 
Address  R A Podar Ayurvedic Medical College Worli Mumbai 18 kayachikitsa department OPD number 18 
Type of Sponsor  Government medical college 
 
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 Deepika Suryawanshi  M A Podar Hospital   R A Podar Ayurveda Medical College Worli mumbai 18 Kayachikitsa Department OPD number 18
Mumbai
MAHARASHTRA 
9901639770

suryavamshideepika86@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
BORS committee of institution r a podar ayurvedic college  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:R730||Abnormal glucose. Ayurveda Condition: PRAMEHA-PURVARUPAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: bhunimbadi churna, Reference: charaka samhita chikitsa sthana Grahanidoshachikitsa Adhyaya shloka number 132-133 , Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 10 Weeks, anupAna/sahapAna: Yes(details: -koshna jal), Additional Information: -"भूनिम्बकटुकाव्योषमुस्तकेन्द्रयवान् समान् । द्वौ चित्रकाद् वत्सकत्वग्भागान् षोडश चूर्णयेत् ॥। । गुडशीताम्बुना पीतं ग्रहà
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1 Age between 21 years to 70 years.

2 Gender - All

3 Subject who are willing to give written informed consent.

4 Patients having signs and symptoms of Prameha purvarupa like Swedatipravritti, Pipasa, Angasada, Nidradhikya and Karapadatala daha.

5 Newly diagnosed with Prediabetes

6 HbA1C 5.7-6.4%

7 BSL Fasting 110-125mg/dl

8 BSL PP140-199 mg/dl 
 
ExclusionCriteria 
Details  1 Prior use of medicine to treat diabetes.

2 Pregnant and lactating women.

3 Patients having complications like CKD, HIV, CA, acute conditions of CHD.

4 Patients who are immunocompromised and who are on immunosuppressant medications.

5 Those patients who are not ready to comply the trial protocol. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
"To evaluate the effect of Bhunimbadi Churna in Prameha Purvarup with special reference to Prediabetes"  Total duration of study: 10 Weeks: - With medicine - 6 Weeks Without medicine - 4 Weeks 
 
Secondary Outcome  
Outcome  TimePoints 
1.To assess the effect of Bhunimbadi churna in symptoms like Nidradhikya, in symptoms like Atiswedpravritti, Pipasa, Nidradhikya, Angasada, Karapadatala daha.  Total duration of study: 10 Weeks: - With medicine - 6 Weeks Without medicine - 4 Weeks 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   11/07/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  11/07/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
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 or the" Veda of life" stands for Indian system of Medicine. The aim of Ayurveda is prolongation of Healthy life, prevention of disease, senility of a person and help a person to attain the four principle aim that is Dharma, Artha, Kam and Moksha. Knowledge of Ayurveda enables one to understand, how to create this balance of body, mind and consciousness. Balance is the natural order, imbalance is the disorder. Health is order, disease is disorder. Within the body there is constant interaction between order and disorder. When we understand the nature and structure of disorder, one can reestablish order.

Prameha is one of the astamahagada described in Ayurveda samhita. This disease which was prevalence in ancient time as mahagada (a disease for which treatment is very difficult) is still most challenging disease in 21st century.

Kaphakrut ch sarvam (prameha) indicates that is vitiated kapha i.e. the main dosha and of all the dushyas it is medas that is primarily entity that is disturbed. According to shatkriyakala, sanchay, prakop, prasar and sthansanshray avastha represents purvarupavastha of disease. Prameha purvarupas are elaborately explained in Ayurveda granthas. In bruhattrayi, Acharya described 20 types of prameha on the basis of predominance of dosha. In samprapti of Prameha, all the three doshas get vitiated mainly kapha along with following dushyas: rasa, rakta, mansa, meda, majja, shukra, lasika, vasa and oaj,

In this era of globalisation, lifestyle is changing day to day. Irregular food habit, lack of exercise, excessive stress, disturbed sleep pattern eventually hampers metabolism giving rise to lifestyle disorders. Prediabetes is a stage which is characterized by blood glucose levels which are above normal but below the diabetes threshold [2] The prevalence of Prediabetes in adults in India is estimated to be 14% - Prediabetes is a precursor before the Diagnosis of DM. If one has Prediabetes we should take important step as early as possible.

Ayurveda samhitas have such wonderful formulations. The kalpa Bhunimbadi Churna is described in Charak chikitsasthan is one of them. Contents are 1) Bhunimba 2) Katuka, 3)Shunthi, 4) Marich, 5) Pippali, 6) Mustak, 7) Indrayava, 8) Chitrakmool, 9) Kutajsal.

This combination of drugs mentioned above helps in sampraptibhanga of prameha and it is easy to available. Taking all this consideration the study is taken up entitled "AN OPEN CLINICAL STUDY TO EVALUATE THE EFFECT BHUNIMBADI CHURNA IN PRAMEHA PURVARUP WITH SPECIAL REFERENCE TO PREDIABETES."
 
Close