| CTRI Number |
CTRI/2024/07/070520 [Registered on: 12/07/2024] Trial Registered Prospectively |
| Last Modified On: |
04/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Curative] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing Bahumutrantaka Rasa and Chandrakala Vati in the treatment of Madhumeha (Type 2 Diabetes Mellitus) |
|
Scientific Title of Study
|
An open label randomized comparative clinical study to evaluate the efficacy of Bahumutrantaka Rasa and Chandrakala Vati in Madhumeha vis-a-vis Type 2 Diabetes Mellitus |
| 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 Sharanya R |
| Designation |
PG Scholar |
| Affiliation |
Rajiv Gandhi University of Health Sciences |
| Address |
Department of PG studies in Kayachikitsa OPD no - 1 JSS Ayurveda Medical College and Hopital 41E Lalithadripura Road Alanahalli
Mysore
Mysore
KARNATAKA
570028
India |
| Phone |
9035508605 |
| Fax |
|
| Email |
sharanya.ramesh03@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh A Udapudi |
| Designation |
Dean, Professor & Head of Kayachikitsa Department |
| Affiliation |
Rajiv Gandhi University of Health Sciences |
| Address |
Department of PG studies in Kayachikitsa OPD no - 1 JSS Ayurveda Medical College and Hopital 41E Lalithadripura Road Alanahalli
Mysore
Mysore
KARNATAKA
570028
India |
| Phone |
9844136277 |
| Fax |
|
| Email |
drrajeshudapudi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sharanya R |
| Designation |
PG Scholar |
| Affiliation |
Rajiv Gandhi University of Health Sciences |
| Address |
Department of PG studies in Kayachikitsa OPD no - 1 JSS Ayurveda Medical College and Hopital 41E Lalithadripura Road Alanahalli
Mysore
Mysore
KARNATAKA
570028
India |
| Phone |
9035508605 |
| Fax |
|
| Email |
sharanya.ramesh03@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bahumutrantaka Rasa will be procured from Virgo UAP Pharma PVT. LTD - GMP certified pharmacy Mahagujarat Ind. Estate, Sarkhej - Bawala Highway, Moraiya - 382213, Ahmedabad, Gujarat, India |
| Chandrakala Vati will be prepared from Shree Dhootapapeshwar Limited - GMP certified pharmacy 135 Nanubhai Desai Road, Khetwadi, Mumbai - 400004, India |
|
|
Primary Sponsor
|
| Name |
Dr Sharanya R |
| Address |
JSS Ayurveda Medical College and Hospital, 41E Lalitadripura Road, Alanahalli Mysore, Karnataka-570028, India |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Shree Dhootapapeshwar Limited |
135, Nanubhai Desai Road, Khetwadi, Mumbai-400004, India |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sharanya R |
JSS Ayurveda Medical College and Hospital |
Department of PG studies in Kayachikitsa OPD no - 1 and IPD JSS Ayurveda Medical College and Hopital 41E Lalithadripura Road Alanahalli
Mysore-570028
Mysore
KARNATAKA |
9035508605
sharanya.ramesh03@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Clearance Committee - Human, JSS Ayurveda Medical College and Hospital, Mysore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E116||Type 2 diabetes mellitus with other specified complications. Ayurveda Condition: MADHUMEHAH/KSHAUDRAMEHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Bahumutrantaka Rasa, Reference: Bharata Bhaishajya Ratnakara, Prameha Chikitsa, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Chandrakala Vati, Reference: Bhaishajya Ratnavali, Prameha Chikitsa, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Age group between 30-70 years irrespective of gender.
2.Non-insulin dependent.
3.FBS level greater than 126 mg/dl.
4.PPBS level greater than 200mg/dl.
5.HbA1C greater than 7% - upto 10%.
6.Subjects taking Allopathic oral Anti-diabetic drugs.
|
|
| ExclusionCriteria |
| Details |
1.Subjects with diagnosed cases of severe systemic diseases like Cardiac Disease, Renal Function Impairment and Pulmonary Tuberculosis.
2.Subjects having complications of Diabetes like Ketoacidosis, Nephropathy and Diabetic wounds.
3.Known subject of any active malignancy.
4.Pregnant women and lactating mothers. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of Bahumutrantaka Rasa and Chandrakala Vati in Madhumeha vis-Ã -vis Type 2 Diabetes Mellitus. |
Pre test - 0th day
Mid test - 31st day
Mid test -61st day
Post test - 91st day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the efficacy of Bahumutrantaka Rasa in Madhumeha vis-Ã -vis Type 2 Diabetes Mellitus.
To evaluate the efficacy of Chandrakala Vati in Madhumeha vis-Ã -vis Type 2 Diabetes Mellitus.
|
Pre test - 0th day
Mid test - 31st day
Mid test - 61st day
Post test - 91st day |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 3 |
|
Date of First Enrollment (India)
|
01/08/2024 |
| 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="1"
Months="6"
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
|
Prameha is characterized by ‘Prabhuta’ and ‘Avila’ Mootrata. Madhumeha is a type of Vataja Prameha, characterized by the passage of excessive urine having quality similar to Madhu. It is one among the Astamahagada. Type 2 Diabetes Mellitus is a heterogeneous condition characterized by varying degrees of Insulin resistance and β-cell dysfunction. It is one of the lifestyle disorders whose prevalence is rising more rapidly in almost all countries. In the present scenario, Santarpanajanya Vikaras are given much importance as it is a very common set of disorders. A sedentary lifestyle such as lack of exercise, sleeping during the daytime, consumption of excessive sweets and oily food, change in dietary habits precipitate the Santarpanajanya Vikaras such as Prameha. India is topped in the world with the highest number of people with Diabetes Mellitus. India has around 101 million people living with Diabetes and another 136 million people in Pre-Diabetes stages. About 422 million people worldwide have Diabetes. Diabetes Mellitus is fast-growing public health challenge of the 21st century as the prevalence rate will be >30% in the next 35 years. India is gaining the status of a potential epidemic with >62 million Diabetic individuals and is expected to double this number by the year 2040. Management of T2DM encompasses lifestyle adjustments, medications and in certain instances insulin therapy. Pharmacotherapy includes a range of oral hypoglycemic drugs. Despite the considerable advancements made in the control of T2DM, there are still problems that persist. These challenges encompass the requirement of treatment strategies, for the mitigation of medication-related adverse effects, mitigation of complications associated with the condition, potential for enhancing positive outcomes in T2DM subjects. Medicines used in the study, Bahumutrantaka Rasa and Chandrakala Vati being herbomineral formulations have Mehahara property, their efficacies are evaluated and compared in the subjects diagnosed with Madhumeha vis-à -vis Type 2 Diabetes Mellitus.
|