| CTRI Number |
CTRI/2022/04/042287 [Registered on: 28/04/2022] Trial Registered Prospectively |
| Last Modified On: |
27/04/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Survey study to find out causes of blood impurities in patients with headache as per ayurved siddhant. |
|
Scientific Title of Study
|
“Cross sectional study to find correlation in Hetu of Raktadushti in Shiroshool 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 |
Dr Monali Ashok Vyas |
| Designation |
MD Scholar Ayurved Samhita and Siddhant |
| Affiliation |
Sumatibhai Shah Ayurved College, Hadapsar, Pune |
| Address |
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 |
| Phone |
8308895974 |
| Fax |
|
| Email |
monali.vyas97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gayatri Sawant |
| Designation |
Associate Professor |
| Affiliation |
Sumatibhai Shah Ayurved College, Hadapsar, Pune |
| Address |
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 |
| Phone |
8275563531 |
| Fax |
|
| Email |
drgssawant@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gayatri Sawant |
| Designation |
Associate Professor |
| Affiliation |
Sumatibhai Shah Ayurved College, Hadapsar, Pune |
| Address |
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 |
| Phone |
8275563531 |
| Fax |
|
| Email |
drgssawant@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 Monali Vyas |
Sane Guruji Arogya Kendra, Malwadi Road, Hadapsar, Pune. |
OPD no 2, Department of Kaychikitsa,Sane Guruji Arogya
Kendra, Malwadi Road,
Hadapsar, Pune.
Pune
MAHARASHTRA
Pune
MAHARASHTRA |
8308895974
monali.vyas97@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:D758||Other specified diseases of bloodand blood-forming organs. Ayurveda Condition: SIRORUK, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Gender-either male or female patients irrespective of caste, occupation, socioeconomic
status.
2. Patients suffering from Shirahshoola or having history of Shirahshoola since past three
months or more. |
|
| ExclusionCriteria |
| Details |
1) Patients having history of head injury.
2) Patients having any severe illness where Shirahshoola manifested as a
symptom like Brain tumour,encephalitis,Glaucoma,Poisoning,Ear infection etc.
3) Patients having history of brain surgeries
4) Patients who suffering from psychological disorders |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
It would be proved that common etiological factor of Raktadushti are same as etiological factors of Shiroshool.
Parameter will be assessed in the form of questionnaire and Case record form related to causes of Raktadushti and Shiroshool |
The day first would be the day of inclusion of the patient on which he/she will be interviewed in this cross sectional study.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study Shirahshool and Raktadushti hetu in detail and to find correlation between them.
|
Total duration of Study will be 18 months. |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
10/05/2022 |
| 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
|
Not yet. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Ayurveda stated,Shira as a Uttamanga.Also it is one of the Dashapranayataniya and included in Trimarma along with Basti and Hridaya.Thus shirah is important part of the body. Tridosha are the basic constituents of every vyadhi and plays important role in etiopathogenesis of diseases.Ayurveda science stated that, to prevent the occurrence of the disease rather to cure it after manifestation The procedure of maintaining equilibrium of body-elements is the objective of science. Thus Nidan Parivarjan is adviced as initial part of treatment in every disease.So one should be aware of the hetu involving in disease. Also it has important role in breaking the etiopathogenesis of disease.For that,study of Hetu Siddhant is important to learn.Thus ,Hetu Siddhant is discussed along with Raktadushti in Shirahshoola. |