| CTRI Number |
CTRI/2023/10/058521 [Registered on: 11/10/2023] Trial Registered Prospectively |
| Last Modified On: |
28/09/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect OF SURYA NAMASKAR WITH AYURVEDIC DRUG FOR PRAMEHA
(PRE-DIABETES MELLITUS)
|
|
Scientific Title of Study
|
THERAPEUTIC ROLE OF SURYA NAMASKAR WITH AYURVEDIC DRUG FOR PRAMEHA
(PRE-DIABETES MELLITUS)
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anjali |
| Designation |
Ph.D. Research Scholar |
| Affiliation |
Institute of Medical sciences |
| Address |
Institute of Medical Sciences Department of Kayachikitsa, Faculty of Ayurveda, BHU
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9716091296 |
| Fax |
|
| Email |
rajputanjali1616@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr O P Singh |
| Designation |
Professor |
| Affiliation |
Institute of Medical Sciences, Banaras Hindu University, Varanasi |
| Address |
Institute of Medical Sciences
Department of Kayachikitsa, Faculty of Ayurveda,BHU
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9415818732 |
| Fax |
|
| Email |
singhopbhu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr O P Singh |
| Designation |
Professor |
| Affiliation |
Institute of Medical Sciences, Banaras Hindu University, Varanasi |
| Address |
Institute of Medical Sciences
Department of Kayachikitsa, Faculty of Ayurveda,BHU
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9415818732 |
| Fax |
|
| Email |
singhopbhu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sir Sundar Lal Hospital,Banaras Hindu University,Institute of Medical Sciences Banaras Hindu University, Varanasi, UGC NON-NET fellowship for BHU Ph.D. Scholar |
|
|
Primary Sponsor
|
| Name |
Department of Kayachikitsa Faculty of Ayurveda Institute of Medical Sciences |
| Address |
Department of Kayachikitsa, Faculty of Ayurveda, Institute of Medical Sciences |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Anjali Rajput |
Sir Sundarlala Hospital |
OPD No. 21, 22
Kayachikitsa Ayurvedic wing Faculty of Ayurveda Institute of Medical sciences Banaras Hindu University,Varanasi, Uttar Pardesh
Varanasi
UTTAR PRADESH |
9716091296
rajputanjali1616@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Institute of Medical Sciences Banaras Hindu University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E089||Diabetes mellitus due to underlying condition without complications. Ayurveda Condition: PRAMEHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Nishamalki, Reference: Ashtang Hridyam Utarsthan adhyay 40/48 by- Vagbhat, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -), Additional Information: -Should take medicine with normal water. | | 2 | Intervention Arm | Lifestyle | - | - | Dinacarya: , Ritucarya: , Acara Rasayana:, Other:Surya Namaskar Intervention for 24 minutes with Nishamalki drug , Pathya/Apathya:no, Pathya:, Apathya: |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Patients ranging BMI (Body Mass Index) is more than 23
Blood Sugar level is 101-125 mg (FBST) and 140-199 mg (PPBS)
Clinical features present in the patients
Willing to participate in the study with written consent
|
|
| ExclusionCriteria |
| Details |
Not taking any other intervention of Ayush system medicines.
Patients suffering from Thyroid, Kidney Disease, Dropsy
Pathological Condition
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the effect of Surya Namaskar on Prediabetic patient. Assessment done by Fasting test and PostPrandial test.
|
90 days study having follow up of 30 days each
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the effect of Surya Namasakar on sugar level of Prediabetic patients. |
90 days study having follow up of 30 days each. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
16/10/2023 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| 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
|
Study design of open labeled randomized control clinical trial is planned for the research work.About 100 patients attending the OPD of Sir Sunderlal hospital, IMS, BHU with condition of Pre-Diabetes will rendomly selected for present study between the age of 30 and 55. Their data will is planned to be collected by using a standred research performa. Blood Test will be done for evaluation in the starting of study and at the time of ending of study for the result record.
Group A (n=50)- Yoga Protocol with Ayurvedic Medicine Group B (n=50) - Ayurvedic Medicine |