| CTRI Number |
CTRI/2024/12/078831 [Registered on: 31/12/2024] Trial Registered Prospectively |
| Last Modified On: |
06/08/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [curative] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical Evaluation of Kamala Arka and Taruni Arka in Hyperpigmentation |
|
Scientific Title of Study
|
Comparative Clinical Study of Kamala Arka and Taruni Arka in Hyperpigmentation |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Khushbu Rajeshbhai Morker |
| Designation |
PG Scholar |
| Affiliation |
J. S. Ayurved Mahavidyalaya |
| Address |
Department of Dravyaguna, J S Ayurved Mahavidyalaya and P D Patel Ayurved Hospital, College Road, Kheda, Nadiad
Kheda
GUJARAT
387001
India |
| Phone |
9353564895 |
| Fax |
|
| Email |
morkerkhushbu1797@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Vidhi Bapna |
| Designation |
Professor and HOD |
| Affiliation |
J. S. Ayurved Mahavidyalaya |
| Address |
Department of Dravyaguna, J S Ayurved Mahavidyalaya and P D Patel Ayurved Hospital, College Road, Kheda, Nadiad.
Kheda
GUJARAT
387001
India |
| Phone |
9428972618 |
| Fax |
|
| Email |
drkumathvidhi29@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Vidhi Bapna |
| Designation |
Professor and HOD |
| Affiliation |
J. S. Ayurved Mahavidyalaya |
| Address |
Department Of Dravyaguna, J S Ayurved Mahavidyalaya and P D Patel Ayurved Hospital, College Road, Kheda, Nadiad.
Kheda
GUJARAT
387001
India |
| Phone |
9428972618 |
| Fax |
|
| Email |
drkumathvidhi29@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Sundar ayurved pharmacy, J S ayurved mahavidyalaya and P D patel ayurved hospital, college road, Kheda, Nadiad 387001, Gujarat, India. |
|
|
Primary Sponsor
|
| Name |
J S Ayurved Mahavidyalaya |
| Address |
J S Ayurved Mahavidyalaya, college road, Nadiad 387001 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Khushbu Rajeshbhai Morker |
J. S. Ayurved Mahavidyalaya |
Department Of Dravyaguna, J S Ayurved Mahavidyalaya and P D Patel Ayurved Hospital, College Road, Kheda, Nadiad.
Kheda
GUJARAT |
9353564895
morkerkhushbu1797@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC for human research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L814||Other melanin hyperpigmentation. Ayurveda Condition: VYANGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kamala Arka, Reference: Arka Prakash, Route: Topical, Dosage Form: Arka, Dose: 5(drops), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: Medicine should be taken in sufficient quantity and applied over the affected area of the face | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Taruni Arka, Reference: Arka Prakash, Route: Topical, Dosage Form: Arka, Dose: 5(drops), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: Medicine should be taken in sufficient quantity and applied over the affected area of the face |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients having signs of hyperpigmentation (dark patches) on face fulfilling the diagnosis will be included |
|
| ExclusionCriteria |
| Details |
1.Patients having any other diseases like AIDS, STD, itching, wound, active acne, burning, eczema, dermatitis and other disorders which lead to fatal condition for the patients.
2.Birth marks and moles will be excluded.
3.Pregnant and lactating women.
4.Patients who are on corticosteroid drugs or immune-suppressants and past history of steroidal use in the last 6 months.
5.Other concomitant skin disease occurring with allergic reaction of any other disease.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in signs of hyperpigmentation |
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Difference in clinical efficacy of Kamala Arka and Taruni Arka |
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
17/01/2025 |
| Date of Study Completion (India) |
15/05/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
This will be submitted in form of dissertation |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This study is Randomized clinical trial to evaluate the effect of Kamala (Nelumbo nucifera Gaertn.)
Arka and Taruni (Rosa centifolia Linn.) Arka on hyperpigmentation. 40 patients fulfilling
the inclusion criteria were selected from OPD and randomly divided into two
groups of 20 patients in each group, receiving Kamala arka (Group A) or
Taruni arka (Group B) externally twice daily for 12 weeks, with efficacy
assessed using the Taylor Hyperpigmentation Scale (THS) and Skin
Hyperpigmentation Index (SHI). Both groups showed significant improvement in
hyperpigmentation severity, with no notable difference between them on THS,
while Kamala arka showed a significantly greater reduction in pigment
intensity on SHI compared to Taruni arka. A higher proportion of
patients achieved complete cure with Kamala arka, and no adverse effects
were reported in either group. Kamala arka proved to be a safe and
effective alternative to Taruni arka for managing hyperpigmentation. |