| CTRI Number |
CTRI/2021/07/034922 [Registered on: 16/07/2021] Trial Registered Prospectively |
| Last Modified On: |
11/07/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Hairfall management with nasya karma |
|
Scientific Title of Study
|
an assessment of effectiveness of tiladi tail pratimarsh nasya in the management of khalitya |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Akshata Satpute |
| Designation |
MD scholar |
| Affiliation |
Dr. G. D. Pol foundation, YMT ayurvedic college and hospital, institutional area, kharghar |
| Address |
Panchakarma dept. Dr. G. D. Pol foundation, YMT ayurvedic college and hospital, institutional area, kharghar
Panchakarma dept. Dr. G. D. Pol foundation, YMT ayurvedic college and hospital, institutional area, khargkharghar
Raigarh
MAHARASHTRA
410210
India |
| Phone |
7020163966 |
| Fax |
27749895 |
| Email |
akshatabedse33@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Akshata Satpute |
| Designation |
MD scholar |
| Affiliation |
Dr. G. D. Pol foundation, YMT ayurvedic college and hospital, institutional area, kharghar |
| Address |
Panchakarma dept. Dr. G. D. Pol foundation, YMT ayurvedic college and hospital, institutional area, kharghar
Panchakarma dept.Dr. G. D. Pol foundation, YMT ayurvedic college and hospital, institutional area, khargkharghar
Raigarh
MAHARASHTRA
410210
India |
| Phone |
7020163966 |
| Fax |
27749895 |
| Email |
akshatabedse33@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kalpana Gholap |
| Designation |
Associate professor |
| Affiliation |
Dr. G. D. Pol foundation, YMT ayurvedic college and hospital |
| Address |
Dr. G. D. Pol foundation, YMT ayurvedic college and hospital, institutional area, kharghar
Dr. G. D. Pol foundation, YMT ayurvedic college and hospital, institutional area, kharghar
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9833971482 |
| Fax |
27749895 |
| Email |
kalpu.gholap@gmail.com |
|
|
Source of Monetary or Material Support
|
| YMT AYURVEDIC MEDICAL COLLEGE AND HOSPITAL |
|
|
Primary Sponsor
|
| Name |
Dr Akshara Satpute |
| Address |
Dr. G. D. Pol foundation, YMT ayurvedic college and hospital, institutional area, kharghar, raighar, Maharashtra 410210 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Akshata Satpute |
Dr. G. D. Pol foundation YMT Ayurvedic college and hospital |
Panchakarma dept,Dr. G. D. Pol foundation YMT Ayurvedic college and hospital institutional area kharghar
Raigarh
MAHARASHTRA |
07020163966
27749895
akshatabedse33@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E00-E89||Endocrine, nutritional and metabolic diseases. Ayurveda Condition: KSHUDRAROGAH, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nasya karma |
total duration of theraphy is 90 days (3 months) |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Duration of hair fall 3 months or more
• Patients presenting with the clinical features of Khalitya (Falling hair) described as per
Ayurveda and Modern science between the age below 45 years, were randomly
selected for the clinical study irrespective of sex, religion, and habitat etc. The patient
who can follow the given instructions thoroughly will be included to this study. |
|
| ExclusionCriteria |
| Details |
1.Patients suffering from any severe systemic illness like SLE, Chronic Liver or renal
disease.
2.Patients suffering from cancer and are under chemotherapy and radiotherapy.
3.K/C/O Hyperthyroidism, Hypothyroidism, Diabetes.
4.Pregnant, Lactating females and females with menstrual disorders, early menopause.
Patients who have been diagnosed to have local disease like alopecia, Tinea capitalis.
5.Patients of darunak, Arunshika and Indralupta.
6.Chronic infections like HIV, secondary syphilis, inflammatory disorders like psoriasis,
dermatitis.
7.Patients taking oral contraceptives,beta blockers,hormonal replacement therapy,ace
inhibitors,retinoids,antidepressants,heparin, warfarin,steroids.
8.Dushtpeenas(Chronic sinusitis),Madyapeet
(Alcoholic),Abalshrotaras(deafness),Krumi, Utklisht dosha conditions. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Hairfall |
Day 0,21,42,90 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Post procedure hairfall and breakage of hair. |
Day 0,21,42,90 |
|
|
Target Sample Size
|
Total Sample Size="37"
Sample Size from India="37"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/08/2021 |
| 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="8"
Days="9" |
|
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
|
The present study is the clinical experimental study for a completion of MD thesis under MUHS university. Total duration of trial is 3year. Title- An assessment of effectiveness of tiladi tail pratimarsh nasya in the management of khalitya. Sample size-37 treated with nasya karma. Study center- Dr. G. D. Pol foundationfoundation OPD and IPD Name of student- Akshata Satpute Name of Guide- Dr. Kalpana Gholap |