| CTRI Number |
CTRI/2019/03/017996 [Registered on: 08/03/2019] Trial Registered Prospectively |
| Last Modified On: |
06/03/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the effect of madhukadya oil nasal drop (nasya) and madhukadya oil nasal drop (nasya) with application of madhukadya oil dabbed cottonpad on head (shiropichu) in hair fall |
|
Scientific Title of Study
|
A comparative study of madhukadya taila nasya and madhukadya taila nasya with shiropichu in Khalitya |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr pooja Dattatraya Nakate |
| Designation |
MD scholar |
| Affiliation |
Sumatibhai Shah Ayurved Mahavidyalaya pune |
| Address |
Sumatibhai Shah ayurved Mahavidyalaya Hadapsar Pune
Hadapsar Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
9850989137 |
| Fax |
|
| Email |
poojanakate11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Maya V Gokhale |
| Designation |
professor and HOD |
| Affiliation |
Sumatibhai Shah ayurved Mahavidyalaya |
| Address |
Sumatibhai Shah ayurved Mahavidyalaya Hadapsar Pune
Hadapsar pune
Pune
MAHARASHTRA
411028
India |
| Phone |
9422323285 |
| Fax |
|
| Email |
drmayagokhale@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr pooja Dattatraya Nakate |
| Designation |
MD scholar |
| Affiliation |
Sumatibhai Shah ayurved Mahavidyalaya Hadapsar Pune |
| Address |
Sumatibhai Shah ayurved Mahavidyalaya Hadapsar Pune
Hadapsar pune
Pune
MAHARASHTRA
411028
India |
| Phone |
9850989137 |
| Fax |
|
| Email |
poojanakate11@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sumatibhai Shah Ayurved Mahavidyalaya Hadapsar Pune |
|
|
Primary Sponsor
|
| Name |
Dr Pooja Dattatraya Nakate |
| Address |
Sumatibhai Shah ayurved Mahavidyalaya Hadapsar Pune |
| 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 |
| Dr Pooja Dattatray Nakate |
Sane Guruji Aarogya Kendra |
Sumatibhai Shah Ayurved Mahavidyalaya Hadapsar Pune
Pune
MAHARASHTRA |
9850989137
poojanakate11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Hair fall |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Madhukadya taila |
Nasya with shiropichu |
| Intervention |
Madhukadya taila Nasya |
Nasya nasal drop
8 drops in each nostril |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
at least or more than 100-150 hair falling daily
use of hair dye or any chemical
nasya arha
shiropichu arha |
|
| ExclusionCriteria |
| Details |
Lactating mother
Known Cases of any systemic disease like hyperthyroidism, cancer
Hereditary baldness
Drug induce hair fall like oral contraceptives, Lithium, Cimetidine
Nasya Anarha
Shiropichu Anarha
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effect of Madhukadya Taila Nasya and Madhukadya Taila Nasya with Shiropichu in Khalitya |
90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the effect of Nasyakarma with Madhukadya Taila in Khalitya
2) To evaluate the effect of Nasya and Shiropichu with Madhukadya taila in Khalitya |
90 days |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
11/03/2019 |
| 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)?
|
|
Brief Summary
|
1. Screening of patients of Khalitya will be done using a purposive sampling method. Followed
by random sampling by lottery method, who meets the inclusion criteria, till
the desired sample size is achieved. 2. 60 patient of Khalitya
will be purposively selected in OPD/IPD basis irrespective of gender, economic
status, religion, occupation.
3 . 60patients will be allocated randomly into two
groups-by Lottery methods.
Group A: 30 patients – Nasya with MadhukadyaTaila
Group B: 30 patients – Nasya with Shiropichu of MadhukadyaTaila.
4. Informed, written and valid consent of the patient will be
taken and included in study records will be maintain in detail case paper. 5. The patients will be assessed on the subjective and objective
parameter.
All patients will be examined during the trial
treatment. Assessment will be based on hair-fall for this purpose score were
given according to severity of hair-fall before and after treatment. 6. Objective parameters:
For hair fall- Test Applied:
1. Running
finger test
2. Comb test |