CTRI Number |
CTRI/2022/05/042346 [Registered on: 02/05/2022] Trial Registered Prospectively |
Last Modified On: |
28/04/2022 |
Post Graduate Thesis |
Yes |
Type of Trial |
Observational |
Type of Study
|
Cross Sectional Study |
Study Design |
Other |
Public Title of Study
|
A survey study of the causes of sciatica from the common causes of vatavyadhi w.s.r to ayurvedic siddhant. |
Scientific Title of Study
|
Cross sectional study of Hetu of Gridhrasee from Samanya Hetu of Vatavyadhi with special
reference to Hetu Siddhant |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Vd Pranjali Ramkrushna Hingane |
Designation |
MD Scholar Ayurved Samhita and Siddhant (Ayurved) |
Affiliation |
Sumatibhai Shah Ayurved College, Hadapsar, Pune |
Address |
OPD no.02,Sane Guruji Arogya Kendra, Malwadi road ,Hadapsar Pune, Department of Ayurved Samhita and Siddhant,MAMs Sumatibhai Shah Ayurved College, Hadapsar, Pune
Pune
Maharashtra
411028
India
Pune MAHARASHTRA 411028 India |
Phone |
7066941295 |
Fax |
|
Email |
pranjalihingane123@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Vd Nilesh Kulkarni |
Designation |
H.O.D., Professor |
Affiliation |
Sumatibhai Shah Ayurved College, Hadapsar, Pune |
Address |
OPD no.02,Sane Guruji Arogya Kendra, Malwadi road ,Hadapsar Pune, Department of Ayurved Samhita and Siddhant,MAMs Sumatibhai Shah Ayurved College, Hadapsar, Pune
Pune
Maharashtra
411028
India
Pune MAHARASHTRA 411028 India |
Phone |
8805335512 |
Fax |
|
Email |
vd.nilesh@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Vd Nilesh Kulkarni |
Designation |
H.O.D., Professor |
Affiliation |
Sumatibhai Shah Ayurved College, Hadapsar, Pune |
Address |
OPD no.02,Sane Guruji Arogya Kendra, Malwadi road ,Hadapsar Pune, Department of Ayurved Samhita and Siddhant,MAMs Sumatibhai Shah Ayurved College, Hadapsar, Pune
Pune
Maharashtra
411028
India
Pune MAHARASHTRA 411028 India |
Phone |
8805335512 |
Fax |
|
Email |
vd.nilesh@gmail.com |
|
Source of Monetary or Material Support
|
Department of Ayurved Samhita and Siddhant,Sane Guruji Arogya Kendra, Malwadi Road, Hadapsar, Pune. |
|
Primary Sponsor
|
Name |
Sane Guruji Arogya Kendra |
Address |
Department of Ayurved Samhita and Siddhant,Sane Guruji Arogya Kendra, Malwadi Road, Hadapsar, Pune. |
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 |
Dr Pranjali Hingane |
Sane Guruji Arogya Kendra, Malwadi Road, Hadapsar, Pune. |
Opd no.02,Department of Kaychikitsa ,Sane Guruji Arogya Kendra, Malwadi Road, Hadapsar, Pune. Pune MAHARASHTRA |
7066941295
pranjalihingane123@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethical Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition:G00-G99||Diseases of the nervous system. Ayurveda Condition: GRUDHRASI, (2) ICD-10 Condition: G55||Nerve root and plexus compressionsin diseases classified elsewhere, |
|
Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
Inclusion Criteria
|
Age From |
30.00 Year(s) |
Age To |
70.00 Year(s) |
Gender |
Both |
Details |
Having lakshana of Gridhrasee
1.Ruk, Toda, Stambha and Muhu-spandana
2.pain starts at Sphik and then radiates to Kati, Prishtha, Uru, janu, jangha, Pada in order
3.Sakthik-shepa-nigraha
4.pain in Payu |
|
ExclusionCriteria |
Details |
1) Amavata
2) Kroshtukshirsh
3) Vatarakta
4) Pregnant Women
|
|
Method of Generating Random Sequence
|
Other |
Method of Concealment
|
Other |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
It would be proved that the common etiological factors for Vata Prakopa are same as the etiological factors of the disease Gridhrasee. Parameter will be assessed in the form of questioner and case record form. |
The day first would be the day of the inclusion of the patient on which he/she will be interviewed in this cross sectional study. Parameter will be assessed in the form of questioner and case record form.
|
|
Secondary Outcome
|
Outcome |
TimePoints |
To study the Hetu of Gridhrasee and Vatavyadhi Hetu in details. and to find correlation between them. |
Total duration of the study will 18 month. |
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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)
|
05/05/2022 |
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="6" 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
|
Ayurveda has wider concepts focusing on findings the factual
cause of Vyadhi thus emphasize on elimination of that cause to prevent its
recurrence and treating then right from roots. Evaluating the root cause of any problem is
halfway of solving it. In medical science immense stress is given to find out,
main causative factor. So, finding the root cause as per mention by Maharshi
in our Ayurvedic texts and get rid of them that is Nidanparivarjana is
important. People falls sick not because of any infection alone, But also due
to three primary cause namely, Asatmya Indriyartha Samyog,
Pragynaparadham and Parinam , these underlyine cause upset the fine
balance among the bioregulating factor of the body – Vata ,Pitta ,Kapha and
make the individual fall prey to opportunistic disease. So, this study is planned to search and correlate the Hetu of
Vatavyadhi which found in Gridhrasi specially in today’s era. So that it could
be ignored from practising and prevention can be done from this attempt we
can minimize the Nidan of Gridhrasi and Swasth Rakshanam motive of
Ayurveda can be achieved. Hence it is necessary to study this thoroughly.
|