| CTRI Number |
CTRI/2024/12/077857 [Registered on: 09/12/2024] Trial Registered Prospectively |
| Last Modified On: |
06/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To see effect of Kantak Panchamool churn in Madhumeh |
|
Scientific Title of Study
|
Open randomized control clinical trial of Kantak panchamool churna in Madhumeh with special reference to DM 2 |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ankita Shankar Pawar |
| Designation |
PG Scholar |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta |
| Address |
OPD no 1 Kayachikitsa department
Sangli MAHARASHTRA 416301 India |
| Phone |
9167446485 |
| Fax |
|
| Email |
ankitapawar1011@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Smita Lokhande |
| Designation |
Associate Professor |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta |
| Address |
OPD no 1 Kayachikitsa department
Sangli MAHARASHTRA 416301 India |
| Phone |
8149556591 |
| Fax |
|
| Email |
yoshitpriya@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Smita Lokhande |
| Designation |
Associate Professor |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta |
| Address |
OPD no 1 Kayachikitsa department
Sangli MAHARASHTRA 416301 India |
| Phone |
8149556591 |
| Fax |
|
| Email |
yoshitpriya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center
Ashta tal walwa dist sangli maharashtra india 416301 |
|
|
Primary Sponsor
|
| Name |
Dr Ankita Shankar Pawar |
| Address |
OPD no 1 Kayachikitsa OPD Ground Floor Dhanvantari Ayurved
Hospital Ashta Tal Walwa Dist Sangli
Maharashtra
India
416301 |
| Type of Sponsor |
Other [(self)] |
|
|
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 Ankita Shankar Pawar |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta |
OPD no 1 Kayachikitsa
OPD Ground Floor
Dhanvantari Ayurved
Hospital Ashta Tal
Walwa Sangli MAHARASHTRA |
9167446485
ankitapawar1011@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta Ethics Committee |
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
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Kantak Panchamool, Reference: Sushrut samhita Dravya samhaniya adhyay 38/74,75, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Koshn jal), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Nisha amalaki churna, Reference: Vaghbhat Uttarsthan 40/48, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Koshn jal), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients aged between 25 to 70 years with irrespective of gender education religion socioeconomic class
2 Patients presenting with classical features of Madhumeha that is
Pipasavridhhi polydipsia
Prabhut mutrata polyuria
Avila mutrata turbidity
Naktamutrata
3 Patients having sign and symptoms of Madhumeha having diagnosis history of 1 yr and newly diagnosed cases |
|
| ExclusionCriteria |
| Details |
1 Patients with Insulin Dependent Diabetes Mellitus-II with history of disease more than 1 yr
2 Patients aged less than 25 years and more than 70 years
3 Patient presenting with Madhumeha due to the complication of other major systemic disease
4 Pregnant women and lactating mothers will be excluded |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the efficacy of Kantak PanchamoolChurna and Nisha amalaki churn in Madhumeha with special reference to DM 2
2 To compare the efficacy of Kantakpanchamool churna & Nishaamalaki Churn in Madhumeha with special reference to DM II
|
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 To review literature of Madhumeha
2 To review literature of DM II
3 To study the untoward effect of Kantak Panchamool Churna if any |
12 months |
|
|
Target Sample Size
|
Total Sample Size="84" Sample Size from India="84"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
20/12/2024 |
| 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 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
|
Diabetes Mellitus is a Metabolic disorder. Characterised by chronic hyperglycaemia with disturbances of carbohydrate, fat & protein metabolism resulting from defects in insulin secretion, insulin action or both. Long term diabetes can causes consequences like brain damage,heart diseases,nephritic,neurotic disease , retinal diseases, amputation that is micro vascular and macro vascular. Diabetes can be correlated to Madhumeha in Ayurveda. Symtopms of Madhumeha like prabhut mutrata ,avil mutrata, pipasaaadhikya can be correlated with polyurea ,urine turbidity ,polydipsia in Diabetes Mellitus type 2.The Prevalence of Diabetes in India is 11.8% according to the National Diabetes and Diabetic Retinopathy Survey report released by the health and family welfare ministry. With increasing incidence of Diabetes Mellitus-II due to changed lifestyle & habits disease has been became as major health issues in society. Disease Progress with many complications leading to cause major illness hampering daily activities of patients. As well as drugs used for treatment also cause many complications. So there is need to aware about disease severity, side effects of modern medicine and modifications in lifestyle. There is need for effective, safe, potent, drug which controls hyperglycemia any adverse reaction and limit the signs symptoms related to Diabetes Mellitustype2. Hence, in the present study will be done on the effects of Kantak panchamula churna on lowering blood sugar level as drug is stated by Sushruta in 38 th chapter of Sushrut sutrasthana.
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