| CTRI Number |
CTRI/2025/11/097345 [Registered on: 13/11/2025] Trial Registered Prospectively |
| Last Modified On: |
12/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic
Screening |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Urine analysis tool for diagnosis of Prameha (diabetes) and its management |
|
Scientific Title of Study
|
Development Of Urine Analysis Tool For Diagnosis Of Prameha And Evaluating Efficacy Of Vaijayanti (Clerodendrum phlomidis ) Decoction In Ikshuvalikameha - An Open Labelled Single Arm Clinical Study |
| 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 Nency Chawda |
| Designation |
Kayachikitsa Postgraduate Scholar |
| Affiliation |
G.J Patel Institute Of Ayurvedic Studies And Research |
| Address |
Department of Kayachikitsa OPD No 14 S.G Patel Ayurveda Hospital And Maternetiy Home New Vallabh Vidyanagar, Anand, Gujarat, India 388120
Anand
GUJARAT
388120
India |
| Phone |
9824224416 |
| Fax |
|
| Email |
NENCY.CHAWDA@ayugjac.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
DrYogesh Deole |
| Designation |
Professor |
| Affiliation |
G.J Patel Institute Of Ayurvedic Studies And Research |
| Address |
Department of Kayachikitsa, OPD NO. 14, S. G. Patel Ayurveda Hospital And Maternity Home, New Vallabh Vidhya Nagar, Anand, Gujarat India-388120
Anand
GUJARAT
388120
India |
| Phone |
9974999309 |
| Fax |
|
| Email |
yogesh.deole@cvmu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nency Jitendrasinh Chawda |
| Designation |
Kayachikitsa Postgraduate Scholar |
| Affiliation |
G.J Patel Institute Of Ayurvedic Studies And Research |
| Address |
Department of Kayachikitsa OPD No 14 S.G Patel Ayurveda Hospital And Maternetiy Home New Vallabh Vidyanagar, Anand, Gujarat, India 388120
Anand
GUJARAT
388320
India |
| Phone |
9824224416 |
| Fax |
|
| Email |
NENCY.CHAWDA@ayugjac.edu.in |
|
|
Source of Monetary or Material Support
|
| G J Patel Institute Of Ayurvedic Studies and Research,Department of Kayachikitsa,New Vallabh Vidhyanagar,Anand-388121 |
|
|
Primary Sponsor
|
| Name |
Dr. Nency Jitendrasinh Chawda |
| Address |
Address Department of Kayachikitsa, G.J Patel Institute Of Ayurvedic Studies
And Research,New V.V Nagar,Anand,Gujarat-388121
|
| 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 Nency Jitendrasinh Chawda |
G.J Patel Institute Of Ayurvedic Studies And Research,S.G.Patel Ayurveda Hospital And Maternity Home |
Department of
Kayachikitsa, G.J Patel
Institute Of Ayurvedic
Studies And Research,
S.G.Patel Ayurveda
Hospital And Maternity
Home, New V.V Nagar,
Anand,Gujarat-388121
Anand
GUJARAT
Anand
GUJARAT |
09824224416
NENCY.CHAWDA@ayugjac.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| G.J.Patel Institute Of Ayurvedic Studies And Research Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E139||Other specified diabetes mellituswithout complications. Ayurveda Condition: PRAMEHAH, (2) 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: Vaijayanti Decoction, Reference: Yadavji Trikamji (editor). Nibandhasangraha Commentary of Sri Dalhanacharya on Susruta Samhita of Susruta, Chikitsasthana, chapter 11, verse no. 09, edition, Varanasi; Chaukhambha Sanskrit Sansthan;2017:290, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: (2) Medicine Name: Vaijayanti Decoction, Reference: Yadavji Trikamji (editor). Nibandhasangraha Commentary of Sri Dalhanacharya on Susruta Samhita of Susruta, Chikitsasthana, chapter 11, verse no. 09, edition, Varanasi; Chaukhambha Sanskrit Sansthan;2017:290, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with classical sign and symptoms of Prameha of having Prabhuta-Avila Mutrata will be included.
Patients suffering from Diabetes mellitus Type 2 less than 5 years of chronicity.
Patients willing to participate in the study.
Patients having FBS value more than 126mg per dl.only for interventional group. |
|
| ExclusionCriteria |
| Details |
Patients on Drugs like Diuretics, Vitamin B complex which affect the urine examination
parameter.
Pregnant and lactating women.
Patients with severe urinary disorders, and other sever clinical condition.
Patients of Diabetes mellitus Type 1.
Patients having the Diabetes mellitus Type 2 more than 5 years.
Patients having uncontrolled diabetes.Only for interventional group. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To develop Ayurvedic diagnostic tool based on urine analysis for diagnosis and treatment of Prameha. |
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The changes in blood glucose levels can be identified by assessing the parameters in the urine examination tool. |
15 Days |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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)
|
15/12/2025 |
| 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
|
|
Diabetes is a
condition that results from lack of the hormone insulin in a person’s blood,
or when the body has a problem using the insulin it produces. Diabetes
prevalence in India has sharply risen recently, with Type 2 diabetes being
the most common form. India holds the highest global prevalence of
non-insulin-dependent diabetes, particularly in the 57-to-64 age range,
reaching 70%. Key risk factors include age, obesity, inactivity, poor diet,
genetics, and
family history. In 2019, non-communicable diseases, including diabetes,
contributed to 74% of global deaths, making diabetes the 9th leading cause of
death worldwide.
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