| CTRI Number |
CTRI/2025/02/080411 [Registered on: 12/02/2025] Trial Registered Prospectively |
| Last Modified On: |
24/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To examine the effect of Madhukadi lepa application in 70 participants (both male and female) of age group between 18 to 30 years with signs of early greying of hairs. |
|
Scientific Title of Study
|
Randomized Controlled Clinical Trial to evaluate the efficacy of Madhukadi lepa in Akala Palitya with special reference to Premature greying of hairs. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Hitali Umesh Parab |
| Designation |
B.A.M.S PG scholar (Shalakyatantra) |
| Affiliation |
LKR Ayurvedic College and Research Centre |
| Address |
Shalakyatantra OPD,1st floor,LKR Hospital,P2 MIDC Area,Shendri Mal,Gadhinglaj, Kolhapur.
P2 MIDC Area, Shendri Mal, Gadhinglaj, Kolhapur 416502.
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
9869644043 |
| Fax |
|
| Email |
hitali99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Raghavendra L Kolachi |
| Designation |
B.A.M.S M.S. Shalakyatantra |
| Affiliation |
LKR Ayurvedic College and Research Centre |
| Address |
Shalakyatantra OPD,1st floor, LKR Hospital,P2 MIDC Area, Shendri Mal,Gadhinglaj, Kolhapur.
P2 MIDC Area,Shendri Mal, Gadhinglaj,Kolhapur 416502.
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
9972616774 |
| Fax |
|
| Email |
ayurraga@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hitali Umesh Parab |
| Designation |
B.A.M.S PG Scholar (Shalakyatantra) |
| Affiliation |
LKR Ayurvedic College and Research Centre |
| Address |
Shalakyatantra OPD,1st floor, LKR Hospital,P2 MIDC Area, Shendri Mal,Gadhinglaj Kolhapur.
P2 MIDC Area,Shendri Mal, Gadhinglaj, Kolhapur 416502.
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
9869644043 |
| Fax |
|
| Email |
hitali99@gmail.com |
|
|
Source of Monetary or Material Support
|
| LKR Ayurvedic College and Research Centre, Gadhinglaj, Kolhapur 416502, India. |
|
|
Primary Sponsor
|
| Name |
Dr Hitali Umesh Parab |
| Address |
6/197, Wadia Estate, Bail bazar, Kurla West, Mumbai 400070. |
| 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 Hitali Umesh Parab |
LKR Ayurvedic College and Research Centre |
Shalakyatantra OPD,1st Floor, LKR Hospital,P2 MIDC Area, Shendri Mal, Gadhinglaj, Kolhapur 416502.
Kolhapur
MAHARASHTRA |
9869644043
hitali99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| LKR Ayurvedic College and Research Centre, Gadhinglaj |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Premature Greying of Hairs. |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Madhukadi lepa , Reference: Ashtang Sangraha Uttartantra 28/106, Route: Topical, Dosage Form: Lepa Churna, Dose: 20(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: Honey), Additional Information: Lepa application every alternate day. | | 2 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Brahmi Bhringraj Hair Mask , Reference: NA, Route: Topical, Dosage Form: Kalka/ Paste, Dose: 20(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: Lepa application every alternate day. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Patient having feature of Akala Palitya.
Patient with no other systemic disorder. |
|
| ExclusionCriteria |
| Details |
Patient with the age less than 18 and more than 30 years. Infectious diseases of scalp like alopecia areata. Akala Palitya associated with diseases like vitiligo, leprosy and albinism. Any other pre diagnosed systemic disorders. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Efficacy of Madhukadi lepa in Akala Palitya |
21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study Akala Palitya |
21 days |
| To study Madhukadi Lepa |
21 days |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
01/03/2025 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is Randomized Controlled Clinical Trial to evaluate the efficacy of Madhukadi lepa in Akala Palitya with special reference to Premature greying of hairs. Total 70 patients of age 18 to 30 years of both sex will be randomly selected for this trial and divided into two groups. Group A - Treated with Madhukadi lepa. Alternate day application (once in a day) over a duration of 21 days (10 applications). Group B - Treated with Brahmi Bhringraj Hair Mask. Alternate day application (once in a day) over a duration of 21 days (10 applications). Data will be analysed and appropriate statistical tests will be applied. Results will be presented. |