| CTRI Number |
CTRI/2024/08/072641 [Registered on: 19/08/2024] Trial Registered Prospectively |
| Last Modified On: |
14/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Preventive |
| Study Design |
Other |
|
Public Title of Study
|
study to check the effect of yoga and yava kalpana in management of prediabetes. |
|
Scientific Title of Study
|
A randomized clinical trial to evaluate the combined effect of yavas kalpana and yoga therapy in management of prediabetes. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Manisha |
| Designation |
PG scholar |
| Affiliation |
Institue for ayurved studies and research,faculty of ayurved kurukshetra. |
| Address |
PG department of Swasthavritta and yoga, Institute for Ayurved studies and research, Shri krishna AYUSH University,Sector 8, umri road Kurukshetra.
Kurukshetra
HARYANA
136118
India |
| Phone |
9468144601 |
| Fax |
|
| Email |
sheokandmanisha0510@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Manisha |
| Designation |
PG scholar |
| Affiliation |
Institue for ayurved studies and research,faculty of ayurved kurukshetra. |
| Address |
PG department of Swasthavritta and yoga, Institute for Ayurved studies and research, Shri krishna AYUSH University,Sector 8, umri road Kurukshetra.
Kurukshetra
HARYANA
136118
India |
| Phone |
9468144601 |
| Fax |
|
| Email |
sheokandmanisha0510@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Manisha |
| Designation |
PG scholar |
| Affiliation |
Institue for ayurved studies and research,faculty of ayurved kurukshetra. |
| Address |
PG department of Swasthavritta and yoga, Institute for Ayurved studies and research, Shri krishna AYUSH University,Sector 8, umri road Kurukshetra.
Kurukshetra
HARYANA
136118
India |
| Phone |
9468144601 |
| Fax |
|
| Email |
sheokandmanisha0510@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute for Ayurved Studies And Research,Shri Krishna AYUSH University,sector 8 umri road ,Kurukshetra 136118,Haryana,India. |
|
|
Primary Sponsor
|
| Name |
Institute for Ayurved Studies And Research,Shri Krishna Ayush University, Kurkshetra |
| Address |
Institute for Ayurved Studies And Research,Shri Krishna AYUSH University,sector 8 umri road ,Kurukshetra 136118 |
| 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 Seema Rani |
,Shri krishna goverment ayurvedic hospital.,kurukshetra |
OPD No. 2,Department of swasthavritta and yoga.Institute For Ayurved Studies and Research, Shri Krishna AYUSH University, Sector-8 Umri road, Kurukshetra-136118
Haryana
India
Kurukshetra
HARYANA |
09466786108
seemaranimd@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Shri Krishna AYUSH University, Kurukshetra |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E70-E88||Metabolic disorders. Ayurveda Condition: PRAMEHA-PURVARUPAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Lifestyle | - | - | Dinacarya: , Ritucarya: , Acara Rasayana:, Other:Yava will be given in porridge or roti form in such a amount that amount will not exceed 100 gm/day/person for three months, Pathya/Apathya:no, Pathya:, Apathya: | | 2 | Intervention Arm | Lifestyle | - | - | Dinacarya: , Ritucarya: , Acara Rasayana:, Other:Procedure Reference: Gehrand samhita, Procedure details: Yoga therapy will be performed for 35-40 minutes once in day.Vajrasan,Dhanurasana,Paschimottanasan,Vrikshasan,Ardhamatsyendrasana,Shavasana for along with pranayam -Anuloma vilomama and Bhramari., Pathya/Apathya:no, Pathya:, Apathya: | | 3 | Intervention Arm | Lifestyle | - | - | Dinacarya: , Ritucarya: , Acara Rasayana:, Other: Yoga therapy will be performed for 35-40 minutes once in day.Vajrasan,Dhanurasana,Paschimottanasan,Vrikshasan,Ardhamatsyendrasana,Shavasana along with pranayam -Anuloma vilomama and Bhramari along with Yava kalpana in porridge or roti form in amount that will not exceed 100gm/day/person, Pathya/Apathya:no, Pathya:, Apathya: |
|
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient sign consent form.
2. BMI greater than 23 kilogram per metersquare.
3. Impaired fasting glucose from 100 miligram per decilitre to 126 miligram per decilitre.
4.Hba1c range 5.7 to 6.4 percent. |
|
| ExclusionCriteria |
| Details |
1.Age below 35 and above 55 years.
2. Patients with history of any chronic disorder or any health challenging diseases.
3. Patients having Impaired fasting glucose less than 100mg/dl and greater than 126mg/dl.
4. Patients having Hba1c Range more than 6.4% and less than 5.7%
5. Patients having hypertension, neuromuscular disease,disc prolapse,osteoarthritisand any type of hernia.
6. Drugs known to influence glycemic status like steroids,antipschychotic,birth control pills,HIV medicines |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To prevent the patient from landing into type 2 diabetes mellitus. |
0,15,30 days and post treatment follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To control Hba1c level |
Pre and post treatment |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
01/09/2024 |
| 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="1"
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
|
The term Pre diabetes or intermediate hyperglycemia is strong risk factor for diabetes mellitus.In Ayurveda Pooravroopas of Prameha are valuable signs and symptoms to predict the disease in early stage and to check its progression towards Madhumeha and its complication by modification of lifestyle .The purpose of this clinical study to evaluate efficacy of Yava’s Kalpana and Yoga therapy on Prediabetes.The study will be conducted in three groups each group comprises 30 patients.Group A receive Yoga therapy for 35-40 min once in a day. Group B receive Yava kalpana twice a day. Group C receive both Yava kalpana and Yoga therapy twice a day.Study time period is one month.Patient’s sign and symptoms will be assesed by subjective and objective parameters.Informed consent will be taken before trial. |