| CTRI Number |
CTRI/2022/04/042143 [Registered on: 25/04/2022] Trial Registered Prospectively |
| Last Modified On: |
23/04/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Preventive |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study on efficacy of Pathya Aahara and Yogic practices in Katigraha. |
|
Scientific Title of Study
|
Katigraha Ke Prabandhana Me Pathya Aahara Tatha Yogika Abhyason Ke Prabhava Ka Chikitsatmaka Adhyayana. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Geeta Rajput |
| Designation |
MD scholar, Swasthvritta And Yoga |
| Affiliation |
Shri NPA Government Ayurveda College Raipur |
| Address |
Shri NPA Government Ayurveda College Raipur (Chhattisgarh)
S-2 priyadarshini nagar ,ring road 1 Raipur Chhattisgarh
Raipur
CHHATTISGARH
492010
India |
| Phone |
7999402121 |
| Fax |
|
| Email |
dr.geetarajput@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anita Sharma |
| Designation |
Professor And HOD Department Of swasthvritta |
| Affiliation |
Shri Narayana Prasad Awasthi Government Ayurveda College Raipur(Chhattisgarh ) |
| Address |
Department of Swasthvritta and Yoga,room no 6,Shri Narayana Prasad Awasthi Government Ayurveda college Raipur (Chhattisgarh)
Shri Narayan Prasad Awasthi Government Ayurveda College Raipur (Chhattisgarh)
Raipur
CHHATTISGARH
492010
India |
| Phone |
9827115211 |
| Fax |
|
| Email |
ansharma260@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sasmita Tripathy |
| Designation |
Reader .Department Of Swasthavritta and Yoga |
| Affiliation |
Shri Narayana Prasad Awasthi Government Ayurveda College Raipur (c.g) |
| Address |
Department of Swasthavritta and Yoga Shri Narayana Prasad Awasthi Government Ayurveda College Raipur Chhattisgarh
Shri Narayana Prasad Awasthi Government Ayurveda College Raipur Chhattisgarh
Raipur
CHHATTISGARH
492010
India |
| Phone |
8763650383 |
| Fax |
|
| Email |
sasmita1980@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri NPA Government Ayurved Collage Raipur Chhattisgarh 492010 India |
|
|
Primary Sponsor
|
| Name |
Shri NPA Government Ayurved Collage RaipurChhattisgarh |
| Address |
Shri NPA Government Ayurved Collage Raipur(Chhattisgarh ) |
| 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 Geeta Rajput |
Shri Khudadad Dungaji Government Ayurved Hospital Raipur (Chhattisgarh) |
OPD No 6 Department of Swasthavritta And Yoga,Shri Khhudadad Dungaji Government Ayurved Hospital Raipur Chhattisgarh
Raipur
CHHATTISGARH |
7999402121
dr.geetarajput@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:M629||Disorder of muscle, unspecified. Ayurveda Condition: Katigraha, (2) ICD-10 Condition:M629||Disorder of muscle, unspecified. Ayurveda Condition: Katigraha, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Lifestyle | - | - | Dinacarya: 1wakeup early in the morning.
2 Take meal at proper time.
3eat fresh fruit.
4 Have morning walk for 20 minutes
5 Go to bed before 10 pm., Ritucarya: Follow aahara and vihara as per Ritu., Acara Rasayana:1 Be positive and belive in God.
2 Practice forgiveness.
3 Advise to speak truth.
4 have patience., Other:, Pathya/Apathya:yes, Pathya:Wheat,rice, munga gram,gooseberry,cow ghee,chaulai,slight ushna jal etc.
Do work according your capability etc., Apathya:katu,tikta,kshaya ras pradhan food,fast food,cold beverages,sheetal jal,liquor etc.
long standing,sitting,driving etc. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients age 18 to 60 years
2. On the basis of classical symtom of Katigrah
will be selected .
3. Patients will be selected irrespective of their
gender,religion,occupation,marital status etc.
4. katigrah disease which is not more than one
year old.
5. Patient, who is willing for follow pathya
aahara and yogasana. |
|
| ExclusionCriteria |
| Details |
1. Patients age less than 18 and more than 60.
2. Katigraha disease which is more than one year
old..
3. Patients suffering from spine releted
disease,spinal injury,congenital deformity,bone
tuberculosis,and any other complicated systemic
disease.
4. patients suffering from disease like vrikka
vridadhi(renal abcess),vataj jwara,kshatkshin,
in which katigraha occurs as a symtom.
5. patient restricted in special aasana.
6. patient not willing for the study. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. coin test
2. S.L.R. test
3. Scober test |
15, 30, 45, 60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| symptoms of katigrah like pain,stiffness,restricted movement etc.will be reduce |
60 days |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
26/04/2022 |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Katigraha is a common health problem all over the world and is the main cause of physical disability.It affects both gender equality.In India more than 60 % people suffering from Katigraha.In Ayurveda Katigraha is mentioned independently and as a symptom of other disease. Katigraha is a disease in which activities are limited due to pain and stiffness in katipradesh.It is a vata dominant disease.When the vata ,which is vitiated due to its irritating reasons comes to the here,it cause distortion in the structure located here.Because of this ,there is distortion in their work .In modern medical science it is called Low back pain.This is due to faulty posture and improper diet The dietary and yogic practice in management of Katigraha have been adopted. Nadishodhan pranayama and certain asana have been taken under yogic practices. |