| CTRI Number |
CTRI/2025/02/080275 [Registered on: 10/02/2025] Trial Registered Prospectively |
| Last Modified On: |
10/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study the effect of KiratatiktaChurna in the management of Prameha with special reference to BSL & HbA1C. |
|
Scientific Title of Study
|
Single Arm Clinical Study To Evaluate Add On Effect Of Kiratatikta Churna In The Management Of Prameha With Special Reference To Blood Sugar Level And HbA1C |
| 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 Kaustubh Kailas Shinde |
| Designation |
PG Scholar |
| Affiliation |
LRP Ayurvedic Medical College and Hospital |
| Address |
LRP Ayurvedic Medical College And Hospital Post Graduate Institute And Research Centre Urun Islampur Department Of Rognidan Avum Vikriti Vigyan,Division No 1,Room No 1
Sangli
MAHARASHTRA
415409
India |
| Phone |
9665451044 |
| Fax |
|
| Email |
kaustubhshinde30@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhay Mahavir Khot |
| Designation |
Reader |
| Affiliation |
LRP Ayurvedic Medical College And Hospital Post Graduate Institute And Research Centre Urun Islampur |
| Address |
LRP Ayurvedic Medical College And Hospital Post Graduate Institute And Research Centre Urun Islampur Department Of Rognidan Avum Vikriti Vigyan Division No 1,Room No 1
Sangli
MAHARASHTRA
415409
India |
| Phone |
9172710091 |
| Fax |
|
| Email |
drabhay1988khot@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhay Mahavir Khot |
| Designation |
Reader |
| Affiliation |
LRP Ayurvedic Medical College And Hospital Post Graduate Institute And Research Centre Urun Islampur |
| Address |
LRP Ayurvedic Medical College And Hospital Post Graduate Institute And Research Centre Urun Islampur Department Of Rognidan Avum Vikriti Vigyan Division No 1,Room No 1
Sangli
MAHARASHTRA
415409
India |
| Phone |
9172710091 |
| Fax |
|
| Email |
drabhay1988khot@gmail.com |
|
|
Source of Monetary or Material Support
|
| LRP Ayurvedic Medical College And Hospital Post Graduate Institute And Research Centre Urun Islampur Tal Walwa Dist Sangli 415409 Maharashtra India |
|
|
Primary Sponsor
|
| Name |
Dr Kaustubh Kailas Shinde |
| Address |
LRP Ayurvedic Medical College And Hospital Post Graduate Institute And Research Centre Urun Islampur Tal Walwa Dist Sangli 415409 Maharashtra |
| 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 Kaustubh Kailas Shinde |
LRP Ayurvedic Medical College And Hospital |
LRP Ayurvedic Medical College And Hospital Post Graduate Institute And Research Centre Urun Islampur Department Of Rognidan Avum Vikriti Vigyan,Division No 1,Room No 1
Sangli
MAHARASHTRA |
9665451044
kaustubhshinde30@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| LRP Ayurvedic Medical College Institutional Ethical 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: PRAMEHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kiratatikta Churna, Reference: Dhanawantari Nighantu/Kiratatikta, Shlok no. 559-561/, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -Koshna Jal), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Diabetic Patient having their Fasting blood glucose level more than 80 mg/dl and less than 120 mg/dl.
2.Diabetic Patient having Post prandial blood glucose level more than 200 mg/dl and less than 350 mg/dl.
3.Diabetic Patient having HbA1C more than 6.5 % and less than 10.5 %.
4Patient who is taking regular Diabetic drugs
|
|
| ExclusionCriteria |
| Details |
1.Patients having age below 35 years and more than 60 years.
2.Acromegaly, Cushing’s syndrome and Pancreatic disorder.
3.Pregnant and lactating women.
4.Patient with gestational diabetes.
5.Patient suffering from Hepatic dysfunction, Renal dysfunction or Liver cirrhosis.
6.Those who are under Insulin therapy [IDDM].
7.Patient with Lactic acidosis, Sepsis.
8.Patients with acute complications like hyperglycemic coma, ketoacidosis and infections like gangrene.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the effect of KiratatiktaChurna in the management of Prameha with special reference to BSL & HbA1C. |
30 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To study the Nidanapanchaka of Prameha according to Ayurveda Samhita.
2.To study Diabetes mellitus according to modern science.
3.To study KiratatiktaChurna in detail.
4.To study the BSL & HbA1C test.
5.To study the efficacy of KiratatiktaChurna in the management of Prameha with special reference to BSL & HbA1C.
|
90 Days |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
21/02/2025 |
| 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="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 is one of the
leading causes of death in the world and India is set to emerge as the diabetic
capital of the world. Prameha
is described as Yapya (not totally curable / difficult to cure) disease, but
the prolonged Ayurvedic treatment will help the person to prevent its
complication and resulting in better life. The diagnosis of Prameha was done on the basis of
symptoms like Mutre-abhidhavanti-pipalikashcha ,
Mukhmadhuryata etc. But now a days with the
help of diagnostic test like BSL,HBA1C
which helps to diagnose
Prameha in early stages. Kiratatikta has medicinal properties. It has Tikta Rasa, Laghu, Ruksha
Guna, KatuVipaka, Sheeta Virya and balances Kapha& Pitta. The scientist
evaluated its potent Hepatoprotective, Anti-inflammatory, Anti-microbial
activities. In
this present study, KiratatiktaChurna is used for the management of Prameha.
Mode of action of Kiratatikta and its effect on Prameha will be studied in this
research work.
Kiratatikta is easily
available, easily administrable and effective in the management of Prameha. So,
the drug will be used for this research study w.s.r. to BSL & HbA1C. |