| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:R730||Abnormal glucose. Ayurveda Condition: PRAMEHA-PURVARUPAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (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: -"à¤à¥‚निमà¥à¤¬à¤•टà¥à¤•ावà¥à¤¯à¥‹à¤·à¤®à¥à¤¸à¥à¤¤à¤•ेनà¥à¤¦à¥à¤°à¤¯à¤µà¤¾à¤¨à¥ समानॠ। दà¥à¤µà¥Œ चितà¥à¤°à¤•ादॠवतà¥à¤¸à¤•तà¥à¤µà¤—à¥à¤à¤¾à¤—ानॠषोडश चूरà¥à¤£à¤¯à¥‡à¤¤à¥ ॥। । गà¥à¤¡à¤¶à¥€à¤¤à¤¾à¤®à¥à¤¬à¥à¤¨à¤¾ पीतं गà¥à¤°à¤¹à |
|
|
|
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." |