| CTRI Number |
CTRI/2022/08/044643 [Registered on: 04/08/2022] Trial Registered Prospectively |
| Last Modified On: |
03/08/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical study to evaluate the efficacy of coconut oil extracted by different methods in Hair care. |
|
Scientific Title of Study
|
A randomised open label comparative clinical study to evaluate the efficacy of Narikela taila (Cocos nucifera Linn.) extracted by different methods for Keshya karma with special reference to hair care. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mahalaxmi |
| Designation |
PG Scholar |
| Affiliation |
Sri Sri College Of Ayurvedic Science and Research |
| Address |
SSCASR Survey No.269/270, B.M. Kaval, Udayapura P.O, Kanakapura Rd, Bangalore.
Bangalore
KARNATAKA
560082
India |
| Phone |
9676698477 |
| Fax |
|
| Email |
mahalakshmi.patwari@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Seema Pradeep |
| Designation |
HOD and Professor of Dept of Dravyaguna |
| Affiliation |
Sri Sri College Of Ayurvedic Science and Research Hospital |
| Address |
SSCASR Survey No.269/270, B.M. Kaval, Udayapura P.O, Kanakapura Rd, Bangalore.
Bangalore
KARNATAKA
560082
India |
| Phone |
9448330936 |
| Fax |
|
| Email |
ayurseema@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Seema Pradeep |
| Designation |
HOD and Professor of Dept of Dravyaguna |
| Affiliation |
Sri Sri College Of Ayurvedic Science and Research Hospital |
| Address |
SSCASR Survey No.269/270, B.M. Kaval, Udayapura P.O, Kanakapura Rd, Bangalore.
Bangalore
KARNATAKA
560082
India |
| Phone |
9448330936 |
| Fax |
|
| Email |
ayurseema@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saptham Food And Beverages Private Limited, Bangalore |
| Sri Sri College of Ayurvedic Science & Research, Bangalore |
|
|
Primary Sponsor
|
| Name |
Dr Mahalaxmi |
| Address |
SSCASR, Survey No.269/270, B.M. Kaval, Udayapura P.O., 21 KM, Kanakapura Rd, Bangalore, Karnataka 560082 |
| 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 Mahalaxmi |
Sri Sri College of Ayurvedic Science & Research Hospital |
Survey No. 189, O.B. Chordahalli, Udayapura Post Kanakapura Road, South, Bengaluru, Karnataka 560082
Bangalore
KARNATAKA |
9676698477
mahalakshmi.patwari@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Sri Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L659||Nonscarring hair loss, unspecified. Ayurveda Condition: KHALITYAM/KHALATI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Narikela taila ( Wood pressed coconut oil ), Reference: Kaiyyadeva Nighantu), Route: Topical, Dosage Form: Taila, Dose: 15(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 48 Days, anupAna/sahapAna: No, Additional Information: In this group Wood pressed coconut oil extracted from Ghani method. | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Narikela taila ( Virgin coconut oil), Reference: Kaiyyadeva Nighantu, Route: Topical, Dosage Form: Taila, Dose: 15(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 48 Days, anupAna/sahapAna: No, Additional Information: In this group Virgin coconut oil extracted from Centrifugal method | | 3 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Narikela ( Refined coconut oil), Reference: Kaiyyadeva Nighantu, Route: Topical, Dosage Form: Taila, Dose: 15(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 48 Days, anupAna/sahapAna: No, Additional Information: In this group refined coconut oil(Market sample ) is used. |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1 Subjects complaining of hair fall and damage
2 Subjects of either gender in the age group of 21-45 years
3 Hair fall less than 100 strands per day |
|
| ExclusionCriteria |
| Details |
1 Subjects with known history of systemic diseases and nutritional deficiencies
2 Subjects who are on medications or on therapies for other illness
3 subjects having any active scalp diseases, Alopecia areata, Androgenetic alopecia and hair transplant
4 Subjects who are undergoing hair treatment |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 60 second hair comb test
2 hair pull test
3 Trichoscopy |
BT- 0 day
AT- 24th day
AT- 48th day
F- 62nd day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Hair fall score 1 -5
Hair roughness score 1-5
Hair volume score 1-5 |
BT- 0th day
AT-24th day
AT-48th day
F- 62nd day |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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)
|
14/08/2022 |
| 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
|
This study is a randomised, open label, parallel group trail comparing the efficacy of Narikela taila ( Coccus nucifera Linn) extracted by different methods for Keshya karma with special reference to Hair care in 45 sample with complain of hair fall less than 100 strands per day and hair damage. |