| CTRI Number |
CTRI/2025/02/080421 [Registered on: 12/02/2025] Trial Registered Prospectively |
| Last Modified On: |
28/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda Preventive |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Managment of Madhumeha (Diabetes type 2) through Kutjadi Kashaya. |
Scientific Title of Study
Modification(s)
|
THE EFFECT OF SUSHRUTOKTA KUTAJADI KASHAYA IN MADHUMEHA WSR TO TYPE 2 DIABETES MELLITUS |
| Trial Acronym |
THE EFFECT OF SUSHRUTOKTA KUTAJADI KASHAYA IN MADHUMEHA WSR TO TYPE 2 DIABETES MELLITUS |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Deepak Prajapati |
| Designation |
MD Scholar |
| Affiliation |
Govt. Ayurveda College and Hospital, Nipaniya Rewa |
| Address |
Dept. Of Samhita Siddhant Govt. Ayurveda College and
Hospital Nipaniya Rewa M.P
Rewa
MADHYA PRADESH
486001
India
Rewa MADHYA PRADESH 486001 India |
| Phone |
7470729626 |
| Fax |
|
| Email |
drdeepakkumarprajapati1997@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Pravanjan Acharya |
| Designation |
professor and HOD |
| Affiliation |
Govt. Ayurveda College and Hospital, Nipaniya Rewa |
| Address |
Dept. Of Samhita Siddhant Govt. Ayurveda College and
Hospital Nipaniya Rewa M.P
Rewa
MADHYA PRADESH
486001
India
Rewa MADHYA PRADESH 486001 India |
| Phone |
9827459956 |
| Fax |
|
| Email |
dr.pravanjan@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr SN Tiwari |
| Designation |
Associate Professor |
| Affiliation |
Govt. Ayurveda College and Hospital, Nipaniya Rewa |
| Address |
Dept. Of Samhita Siddhant Govt. Ayurveda College and
Hospital Nipaniya Rewa M.P
Rewa
MADHYA PRADESH
486001
India
Rewa MADHYA PRADESH 486001 India |
| Phone |
7581808285 |
| Fax |
|
| Email |
drsntiwari9@gmail.com |
|
|
Source of Monetary or Material Support
|
| Govt Ayurveda College and Hospital Nipaniya Rewa |
|
|
Primary Sponsor
|
| Name |
Govt Ayurveda College and Hospital Nipaniya Rewa |
| Address |
Dept. of Samhita Siddhant Govt. Ayurveda College and
Hospital Nipaniya Rewa |
| 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 deepak prajapati |
Govt.Ayurveda College Nipaniya Rewa m.p |
Dept.of Samhita Siddhant Govt.ayurveda college nipaniya
rewa m.p
Rewa
MADHYA PRADESH
486001
India Rewa MADHYA PRADESH |
7470729626
drdeepakkumarprajapati1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Govt. Auto. Ayurveda College and Hospital Nipaniya Rewa |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E118||Type 2 diabetes mellitus with unspecified complications. Ayurveda Condition: MADHUMEHAH/KSHAUDRAMEHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kutajadi Kashaya, Reference: su.chi 11/8, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 30(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: Lukewarm water), Additional Information: NIL |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients fulfilling the Diagnostic criteria with classical symptoms of Madhumeha
Patients of both sexes in the age group of 30-65 years.
Patients who are willing to give written consent for participation in this study.
|
|
| ExclusionCriteria |
| Details |
Patients with juvenile diabetes.
Patients having IDDM and receiving insulin (type 1).
Excessive blood glucose (FBS) greater than 375 mg/dl and (PPBS) greater than 500 mg/dl.
HbA1c greater than 9.0 percent.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in subjective parameters like 1. Prabhuta mutrata,Avila mutrata,Kshuadhikya,Pipasa adhikya,Nidradhikya, Baddhata |
0 to 21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the effect of trial drugs in improving
the signs, symptoms as per assessment criteria |
after 21 days |
|
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
25/04/2025 |
| 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 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
|
TITLE : EFFECT OF SUSHRUTOKTA KUTAJADI KASHAYA IN MADHUMEHA W.S.R. TO TYPE 2 DIABETES MELLITUS. AIM : To assess the effect of Sushrutokta Kutajadi Kashaya in Madhumeha w.s.r. to Type 2 Diabetes Mellitus. OBJECTIVE : To describe the probable mode of action of Kutajadi Kashaya in treatment of Madhumeha. To assess the efficacy of Sushrutokta Kutajadi Kashaya in improvement of clinical manifestations of Madhumeha. INTRODUCTION: Diabetes Mellitus type 2 in ayurveda correlate with madhumeha under the heading of prameha described in bruhatrayee and laghutrayee, mostly observed in age group 30 to 50 years of age . Amongst the many dreadful conditions arising because of modern,day living, Diabetes Mellitus is a giant disease considered as one of the archenemies of the humankind caused by improper diet and lifestyle. It is often referred to as a silent killer. Diabetes and its complications pose a major threat to public health resources throughout the world. Looking at its gravity, the World Health Organization WHO has taken up a close vigilance and survey about this problem the world over. The WHO statement on primary health care program states that there is a collective failure to deliver in line with these values which is painful and deserves our greatest attention. Also there is an inability of health services to deliver the level of national coverage that meets the stated demand and changing needs. This scientific holistic work inspired from Ayurveda with a special focus on diet and lifestyle can seriously contribute into the DM management and primary health care program. Taking these facts into consideration, the present study was undertaken to evaluate the effect of Ayurvedic diet and lifestyle with Kutajadi Kwatha in Madhumeha .
NEED OF RESEARCH: The prevalence of diabetes in India has risen from 7.1% in 2009 to 8.9% in 2019, 25.2 million adults are estimated to have diabetes, which is estimated to increase to 35.7 million in the year 2045. India ranks second after China in the global diabetes epidemic with 77 million people with diabetes. Of these, 12.1 million are aged >65 years, which is estimated to increase to 27.5 million in the year 2045. It is also estimated that nearly 57% of adults with diabetes are undiagnosed in India, which is approximately 43.9 million. Thus, measures of controlling and prevention of diabetes need to be done so as to manage and prevent the disease accordingly. STUDY DESIGN: · Study type : Interventional · Purpose : Treatment · Maskingn : Open labelled clinical trial · Direction : Prospective · End Point : Efficacy · No. of group : single group TREATMENT REGIMEN: - Drug Kutajadi Kashaya
- Form Kashaya
- Duration 30 days
- Follow Up 06 months.
- Dose 30 ml twice a day before meal.
- Anupana lukewarm water koshna jala
DRUG -
Kutajadi Kashaya Su.Chi.11/8
CONTENT:
1. Kutaja
2. Kapittha
3. Rohitaka
4. Bibhitaka
5. Saptaparna PROBABLE MODE OF ACTION: All pramehas are tridoshaja while kutajadi kashaya is tridosha shamaka. kutajadi kashaya having tikta kashaya rasa, ushna virya anti hypoglycaemic property. kutajadi kashaya is tikta kasaya rasa pradhana having katu vipaka and ushna virya with laghu,ruksha guna predominance. Practically most of patients.with madhumeha having history of consumption of viruddha ahara and unhealthy life style as described in ayurveda leads to excessive vitiation of kapha, pitta, meda, mamsa dhatu is responsible for madhumeha. So considering the kapha,mamsa,meda predominance in madhumeha tikta kasaya rasa and katu vipak,ushna virya of kutjadi kashaya will be best kapha,mamsa,meda shamaka. Laghu ruksha guna and tikta kashaya rasa of kutajadi Kashaya with its deepana pachana karma helps improve metabolism by the properties of amapachana Ushna virya of kutajadi kashaya acts as vata shamaka, stroto shodhaka and kledaka shoshaka, eliminates morbid doshas accumulated in the body RESEARCH QUESTION: Is Kutajadi Kashaya effective in relieving the symptoms of Madhumeha when taken for 30 days ? HYPOTHESIS: NULL HYPOTHESIS: H0 Kutajadi Kashaya is not effective in relieving the symptoms of Madhumeha. ALTERNATE HYPOTHESIS:
H1 Kutajadi Kashaya is effective in relieving the symptoms of Madhumeha
|