| CTRI Number |
CTRI/2021/02/031095 [Registered on: 08/02/2021] Trial Registered Prospectively |
| Last Modified On: |
13/06/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
Effect of Abhraka Bhasma Amrutikarana in type 2 diabetes |
|
Scientific Title of Study
|
Pharmaceutical standardization and comparative clinical efficacy of Abhraka Bhasma (with and without Amrutikarana) in the management of Type 2 Diabetes (Madhumeha) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Om Pandey |
| Designation |
PhD scholar |
| Affiliation |
ITRA,Gujarat Ayurved University |
| Address |
Room no 52, PG Boys hostel, Institute of Post Graduate Teaching and Research In Ayurveda Gujarat Ayurved University Jamnagar 361008 Gujarat India
2nd floor Department of Rasashastra and Bhaishajya kalpana Institute of Post Graduate Teaching and Research In Ayurveda Gujarat Ayurved University Jamnagar 361008 Gujarat India
Jamnagar
GUJARAT
361008
India |
| Phone |
8004801212 |
| Fax |
|
| Email |
dr.ompandey07@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prashant Bedarkar |
| Designation |
Associate professor dept. of RS and BK ITRA |
| Affiliation |
ITRA Gujarat Ayurved University Jamnagar |
| Address |
2nd floor Department of Rasashastra and Bhaishajya kalpana Institute of Post Graduate Teaching and Research In Ayurveda Gujarat Ayurved University Jamnagar 361008 Gujarat India
Gujarat, India.
Department of Rasashastra and Bhaishajya kalpana Institute of Post Graduate Teaching and Research In Ayurveda Gujarat Ayurved University Jamnagar 361008 Gujarat India
Jamnagar
GUJARAT
361008
India |
| Phone |
9316876572 |
| Fax |
|
| Email |
drprashantbedarkar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prashant Bedarkar |
| Designation |
Associate professor dept. of RS and BK ITRA |
| Affiliation |
ITRA Gujarat Ayurved University Jamnagar |
| Address |
2nd floor Department of Rasashastra and Bhaishajya kalpana Institute of Post Graduate Teaching and Research In Ayurveda Gujarat Ayurved University Jamnagar 361008 Gujarat India
Gujarat, India.
2nd floor Department of Rasashastra and Bhaishajya kalpana Institute of Post Graduate Teaching and Research In Ayurveda Gujarat Ayurved University Jamnagar 361008 Gujarat India
Jamnagar
GUJARAT
361008
India |
| Phone |
9316876572 |
| Fax |
|
| Email |
drprashantbedarkar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute For Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University Jamnagar 361008 |
|
|
Primary Sponsor
|
| Name |
Institute for Post Graduate Teaching and Research in Ayurveda |
| Address |
GUJARAT AYURVED UNIVERSITY CAMPUS JAMNAGAR 361008 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Om Pandey |
Institute for Post Graduate Teaching and Research in Ayurveda |
OPD no 8 Institute for Post Graduate Teaching and Research in Ayurveda campus of Gujarat Ayurved University Jamnagar Gujarat India 361008
Jamnagar
GUJARAT |
8004801212
dr.ompandey07@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE FOR POST GRADUATE TEACHING AND RESEARCH IN AYURVEDA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E119||Type 2 diabetes mellitus without complications. Ayurveda Condition: MADHUMEHAH/KSHAUDRAMEHAH, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Abhraka Bhasma with Amrutikarana |
In treatment group patients will be treated with 1 tablet (187.5mg Abhraka Bhasma with Amrutikarana + 62.5mg Triphala Ghana) twice a day 15 min. before meal for 8 weeks and follow up for 4 weeks. |
| Comparator Agent |
Abhraka Bhasma without Amrutikarana |
In treatment group patients will be treated with 1 tablet (187.5mg Abhraka Bhasma without Amrutikarana + 62.5mg Triphala Ghana) twice a day 15 min. before meal for 8 weeks and follow up for 4 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Either the sexes having age between 18 to 60 years.
Patients having chief & associated complains of Madhumeha (Prabhuta-Avilamutrata, pipashadhikya, kshudhadhikya etc.)
Patients with stable continuous dose of modern medicine for more than 1 month.
Known patient of Type 2 Diabetes and also the preliminarily diagnosed patients on the basis of signs and symptoms of the disease are confirmed by FBS and PPBS.
|
|
| ExclusionCriteria |
| Details |
Age more than 60 and below18 years
Prameha pidika (Diabetic nonhealing wound), Systemic infection, active infection other than superficial mild skin infestation
Secondary Diabetes mellitus and Diabetes mellitus Type 1
Patients of any other severe illness.
Malignant and accelerated hypertensive.
Other chronic debilitating diseases.
Pregnant woman and expecting conception (within six month)
Lactating mothers.
Patients with fatal diabetic complication like end stage renal disease
Patient with diabetic ketoacidosis
Severe anaemia below 7gm% Hb.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Control in blood sugar level and symptomatic relief |
2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improved quality of life |
2 months |
|
|
Target Sample Size
|
Total Sample Size="102"
Sample Size from India="102"
Final Enrollment numbers achieved (Total)= "101"
Final Enrollment numbers achieved (India)="101" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/02/2021 |
| Date of Study Completion (India) |
25/03/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Indian population with type 2 diabetes has a high burden (76.6%) of poor
glycemic control. In Ayurveda Diabetes mellitus is compared with Madhumeha
and classified under Vataja Prameha. Abhraka is a wonder drug
described under Rasashastra branch with predominant Rasayana and Yogavahi
properties. Abhraka is mostly prescribed
in the form of Bhasma after several processing steps like Shodhana,
Dhanyabhraka Nirmana, Marana, Amrutikarana etc. Amrutikarana is a special procedure to eliminate all remaining Doshas from the
prepared Bhasma without impairing the therapeutic efficacy of the end
product. Since no previous research works has been found for the revalidation
of this fact in therapeutic efficacy of Abhraka Bhasma in diabetes,
hence present research work is an effort to establish a link between the effect
of Amrutikarana and therapeutic efficacy of Abhraka Bhasma in Madhumeha. Abhraka Bhasma will be prepared by 60 cycles of incineration and then Amrutikarana will be carried out in one group. Then clinical study will be carried out in type 2 diabetes (Madhumeha) patients. Treatment group 1: 1 Tablet (187.5 mg Abhraka Bhasma prepared with Amrutikarana and 62.5 mg Triphala Ghana) twice daily Treatment group 2: 1 Tablet (187.5 mg Abhraka Bhasma prepared without Amrutikarana and 62.5 mg Triphala Ghana) twice daily Dose: 187.5 mg BD Adjuvant: Water in sufficient quantity Time of administration: 15 min before meal Study duration: 8 weeks Follow up: 4 weeks Concurrent medications or treatments for diabetes: Patients on continued
medication from any medical system will be allowed to continue their
medications during the treatment and follow up period (except insulin). The
research drug will be on addon basis during the treatment period. If patient
has no previous drug history, he/she will receive the research drug only. |