| CTRI Number |
CTRI/2024/05/068207 [Registered on: 31/05/2024] Trial Registered Prospectively |
| Last Modified On: |
21/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To see the effect of intervention of effect of jamun seed powder and ardh-matsyendra yoga on the pre-diabetic patient |
|
Scientific Title of Study
|
A study on the effect of jamun (Syzygium Cumini) Seed Powder and Ardh-Matsyendra asana on the prediabetic patient. |
| 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 Vijay Laxmi Gautam |
| Designation |
Professor |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Rachana Sharir Faculty of Ayurveda Institute of Medical Sciences Banaras Hindu University Varanasi
UTTAR PRADESH
221005
India
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9451440263 |
| Fax |
|
| Email |
vlaxmi40@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Neha Pandey |
| Designation |
PhD Scholar |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Rachana Sharir Faculty of Ayurveda Institute of Medical Sciences Banaras Hindu University Varanasi
UTTAR PRADESH
221005
India
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9794811811 |
| Fax |
|
| Email |
1994npandey@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Neha Pandey |
| Designation |
PhD Scholar |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Rachana Sharir Faculty of Ayurveda Institute of Medical Sciences Banaras Hindu University Varanasi
UTTAR PRADESH
221005
India
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9794811811 |
| Fax |
|
| Email |
1994npandey@gmail.com |
|
|
Source of Monetary or Material Support
|
| 1.Department of Rachana Sharir Faculty of Ayurveda IMS BHU 2. Kayachikitsa OPD Sir Sundarlal Hospital BHU |
|
|
Primary Sponsor
|
| Name |
Banaras Hindu University |
| Address |
Lanka Varanasi 221005 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Rajendra Prasad |
Department of Kayachikitsa Faculty of Ayurveda IMS BHU |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rajendra Prasad |
Sir Sunder Lal Hospital, BHU |
Room no. 22, department of kayachikitsa, faculty of Ayurveda
Varanasi
UTTAR PRADESH |
9411471910
rajendraprasad51@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IMS BHU 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: prameha-purvarupam, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | not applicable | (Procedure Reference: none, Procedure details: Ardha matsyendrasana, a seated twist pose, is the ninth of the 12 basic poses in Hatha yoga.
• To come into Ardha Matsyendrasana, from dandasana, the right knee is bent to place the foot around the left hip. The left knee is raised placing the left foot beside the outer right knee. The neck is then twisted looking to the left. The right arm is extended outside the left knee to grab the left foot. This asana should be followed 15-20 minutes twice daily
Ardha matsyendrasana has a wide range )
| | 2 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Syzygium Cumini, Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Years, anupAna/sahapAna: No, Additional Information: - | | 3 | Intervention Arm | Procedure | - | not applicable | (Procedure Reference: none, Procedure details: Ardha matsyendrasana, a seated twist pose, is the ninth of the 12 basic poses in Hatha yoga.
• To come into Ardha Matsyendrasana, from dandasana, the right knee is bent to place the foot around the left hip. The left knee is raised placing the left foot beside the outer right knee. The neck is then twisted looking to the left. The right arm is extended outside the left knee to grab the left foot. This asana should be followed 15-20 minutes twice daily
Ardha matsyendrasana has a wide range )
(1) Medicine Name: Syzygium Cumini, Reference: none, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Duration: 3 Months |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient having Fasting Glucose Level between 100-125 mg/dL and Glucose Tolerance Level Between 140-199mg/dL 2.Patient having HbA1c 5.7-6.4% |
|
| ExclusionCriteria |
| Details |
1. Patient having Fasting Glucose Level less than 100 and more than 125 mg/dL and Glucose Tolerance Level less than 140 and more than 199mg/dL
2. Patient having HbA1c less than 5.7 and more than 6.4%
3. Pregnant and lactating women |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Jamun (Syzyguim cumini) seed powder & Ardha-Matsyendra Asana
modification may have assessed on the different
subjective parameters like frequency of polyuria, polydipsia, polyphagia
|
1 month for 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
assessment of subjective parameter such as lipid profile,
hbA1c, CBC on 105 prediabetic patient to see the effect of jamun seed powder and Ardh-Matsyendra Asana. |
1 month for 3 month |
|
|
Target Sample Size
|
Total Sample Size="105"
Sample Size from India="105"
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 |
|
Date of First Enrollment (India)
|
20/06/2024 |
| 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="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - 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 - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- 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 [199npandey345156@gmail.com].
- For how long will this data be available start date provided 01-12-2024 and end date provided 01-12-2027?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Prediabetes is the initial stage of diabetes and a treatable. We can prevent it from turning in diabetes through Ayurvedic medicine/herbs, diet and yoga. Prediabetes is lifestyle disease that is required the person living with the disease to self-manage and make numerous daily decisions regarding food, activity and medications. Integrating the preventive as well as therapeutic approaches of Ayurveda through lifestyle and diet changes in the comprehensive care of Prediabetes is need of the time. Effective management needs drug and measures to minimize sugar and improve the symptoms & well-being of the patients. In this concern we have selected Jamun seed powder and Ardha-Matseyendra asana to observe its efficacy in prediabetic patient. Jamun is one of the Rasayana-Drug, which is recommended for daily use along with other dietary regiments.
tools and investigations to be employed for the assessment of trial intervention- a) subjective parameter- polyurea, polydipsia, polyphagia, and tiredness b) objective parameter- glycaemia test, lipid profile c) Anthropometric parameter- height, weight, waist circumference |