| CTRI Number |
CTRI/2024/01/061587 [Registered on: 18/01/2024] Trial Registered Prospectively |
| Last Modified On: |
27/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
clinical evaluation of Panchtikta Churna in Madhumeha (type 2 Diabetes Mellitus) |
|
Scientific Title of Study
|
Evaluation of Hypoglycemic activity (invitro) and clinical efficacy of Panchtikta Churna in Madhumeha (type 2 Diabetes Mellitus): A Preliminary 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 Rishabh rathore |
| Designation |
MD Scholar |
| Affiliation |
A and U Tibbia college and Hospital |
| Address |
Department of Dravyaguna
A and U Tibbia college and hospital karol bagh New Delhi
Central
DELHI
110005
India |
| Phone |
8982118464 |
| Fax |
|
| Email |
rishabhrathore06@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shalini Varshney |
| Designation |
Assistant Professor |
| Affiliation |
A and U Tibbia college and Hospital |
| Address |
Department of Dravyaguna
A and U Tibbia college and Hospital Karol bagh New Delhi
Central
DELHI
110005
India |
| Phone |
9354925050 |
| Fax |
|
| Email |
shalinidr.v7@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shalini Varshney |
| Designation |
Assistant Professor |
| Affiliation |
A and U Tibbia college and Hospital |
| Address |
Department of Dravyaguna
A and U Tibbia college and Hospital Karol Bagh New Delhi
Central
DELHI
110005
India |
| Phone |
9354925050 |
| Fax |
|
| Email |
shalinidr.v7@gmail.com |
|
|
Source of Monetary or Material Support
|
| A and U Tibbia College and Hospital |
|
|
Primary Sponsor
|
| Name |
Ayurvedic and Unani Tibbia college |
| Address |
Ayurvedic and Unani Tibbia college and Hospital Karol Bagh New Delhi 110005 |
| 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 Rishabh Rathore |
A and U Tibbia College and Hospital |
OPD NO 18, Ekal Dravya, A & U Tibbia College & Hospital
Karol Bagh, New delhi-110005
Central
DELHI |
8982118464
rishabhrathore06@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional 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: Madhumeha, (2) ICD-10 Condition:E119||Type 2 diabetes mellitus without complications. Ayurveda Condition: MADHUMEHAH/KSHAUDRAMEHAH, (3) ICD-10 Condition:E119||Type 2 diabetes mellitus without complications. Ayurveda Condition: MADHUMEHAH/KSHAUDRAMEHAH, (4) ICD-10 Condition:E119||Type 2 diabetes mellitus without complications. Ayurveda Condition: MADHUMEHAH/KSHAUDRAMEHAH, (5) 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 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Panchatikta churna, Reference: Charak samhita, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: normal water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of age group 18 to 60 years of either sex.
2. Fasting plasma glucose ≥ 126 mg/dl or Post Prandial glucose level ≥ 200 mg/dl.
3. The HbA1c levels should lie within the range of> 6.5% to <8.5%
( According to American Diabetes Association, ADA ,2022 guidelines) |
|
| ExclusionCriteria |
| Details |
1. Patients having sign and symptoms of complication of Type 2 Diabetes Mellitus like Nephropathy,
Retinopathy, Neuropathy.
2. Patients with gestational diabetes mellitus or pregnant women .
3. Patients suffering from any chronic diseases such as Bronchial asthma , COPD, Chronic kidney disease ,
Ischaemic heart diseases , Fatty liver stage 3 and Chronic illness of other body organs , uncontrolled High
blood pressure (Systolic more than 160 and diastolic more than 100 mm of Hg)
4. Patients who are diagnosed with malignancy of any system.
5. Patients currently using oral hypoglycemic agents (Conventional). |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decrease in HbA1c values in patients |
3 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 20% decrease in Fasting blood sugar or PP blood sugar or HbA1c. |
3 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
20/01/2024 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [rishabhrathore06@gmail.com].
- For how long will this data be available start date provided 29-11-2023 and end date provided 29-11-2028?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Increasing prevalence of type 2 diabetes mellitus (DM) has become alarming, burdening health care
systems throughout the world. According to international diabetes federation in 2005 confirmed that
diabetes is one of the most common non- communicable disease globally and constitutes the 4 th or 5th
leading cause of death in most developed as well as many developing countries. In India number of
estimated cases of diabetes will be 79.4 million by 2030 as compared to 31.7 million in 2000. India is
deemed as the world’s capital of diabetes.In Priya
Nighantu(Haritakyadi varga) acharya describes Panchtikta churna is a combination of five medicinal
plants having tikta rasa predominately named Saptaparna (Alstonia scholaris bark), Nimba twak ( bark of
Azadirachta indica A. Juss.), Rasna (Pluchea lanceolata leaf), Bhunimba ((Andrographis paniculata
Nees whole plant) and Patola patra (leaves of Tricosanthes dioica Roxb.) . All these ingredients
mainly have Tikta, Kashaya Rasa, Laghu and Ruksha Guna, Katu Vipaka and Ushna Virya. These drugs
having Pitta hara, Jwarahara and Swashara properties. Many herbal formulations found effective as hypoglycemic agent in various research
studies. Here an attempt is made to arrive at a herbal alternative for diabetes, they are devoid of side
effects, can be, collected easily and commonly available, making them very cost effective. Acharya
Charak has described Panchtikta Panchaprasratika Basti in siddhi sthan which is used for the treatment
of prameha , abhishyand, kustha. In the previous study Panchatikta Panchaprasritika Basti was found
effective in diabetic condition . As administration of basti for patients are not very much comfortable
and admission required and its effect on glycosylated haemoglobin (HbA1c) was not assessed, so
Keeping these facts in mind this study is designed to explore the hypoglycemic effect of Panchatikta
churna in Vitro and on oral administration in patients. |