CTRI

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CTRI Number

CTRI/2025/04/084285 [Registered on: 07/04/2025] Trial Registered Prospectively

Last Modified On:

28/03/2025

Post Graduate Thesis

Type of Trial

Interventional

Type of Study

Drug
Ayurveda

Study Design

Single Arm Study

Public Title of Study

Effectiveness of Herbal Ghee with Manjistha and Khadira in Reducing Dark Patches on the Face (Facial Hyperpigmentation)

Scientific Title of Study

To study the efficacy of Manjistha and Khadira yukta Shatadhauta ghrita on Vyanga w.s.r. Facial Melanosis

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 Vivek M
Designation	Assistant Professor
Affiliation	Parul Institute of Ayurved And Research
Address	Department of Swasthavritta and Yoga, Parul Institute of Ayurved And Research, At post Ishwarpura, Tal. Waghodia, Vadodara Vadodara GUJARAT 391760 India
Phone	7829556463
Fax
Email	drvivekmanohar@gmail.com

Details of Contact Person
Scientific Query

Name	Ms. Khushi Patel
Designation	4th Year UG student
Affiliation	Parul Institute of Ayurved And Research
Address	Parul Institute of Ayurved And Research, At post Ishwarpura, Tal. Waghodia, Vadodara Vadodara GUJARAT 391760 India
Phone	9409577036
Fax
Email	workworld019@gmail.com

Details of Contact Person
Public Query

Name	Dr Vivek M
Designation	Assistant Professor
Affiliation	Parul Institute of Ayurved And Research
Address	Department of Swasthavritta and Yoga, Parul Institute of Ayurved And Research, At post Ishwarpura, Tal. Waghodia, Vadodara GUJARAT 391760 India
Phone	7829556463
Fax
Email	drvivekmanohar@gmail.com

Source of Monetary or Material Support

Parul University, Post Limda, Waghodia, Gujarat 391760

Primary Sponsor

Name	Parul University
Address	P.O. Limda, Tal. Waghodia, Dist. Vadodara - 391760
Type of Sponsor	Private medical college

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr B G Kulkarni	Khemdas Hopsital	Swasthavritta and Yoga OPD 9, Khemdas Hospital, Parul Institute of Ayurved and Research, P O Ishwarpura, Vadodara 391760 Vadodara GUJARAT	9480302935 piaresearch@paruluniversity.ac.in

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethical Commitee IEC-PIARHR	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

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

Inclusion Criteria

Age From	18.00 Year(s)
Age To	50.00 Year(s)
Gender	Both
Details	Individuals between age group of 18-50 years having complaint of Vyanga will be included. Individuals will be selected irrespective of sex and socio-economic status.

ExclusionCriteria

Details

Individuals suffering from secondary skin disorders will be excluded.
Individuals with adverse reaction will be excludes from study.
Individual suffering from inflammatory pigmentation, Addison’s disease, Cushing syndrome and hyperpigmentation by birth.

Method of Generating Random Sequence

Method of Concealment

Blinding/Masking

Primary Outcome

Outcome	TimePoints
Effect of Manjistha and Khadira yukta Shatadhauta ghrita in the management of Vyanga over the course of 30 days	15th, 30 day

Secondary Outcome

Outcome	TimePoints
To study the preventive aspect of Manjistha and Khadira yukta Shatadhauta ghrita in recurrence of Vyanga.	30th day

Target Sample Size

Total Sample Size="15"
Sample Size from India="15"
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

Date of First Enrollment (India)

08/04/2025

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="0"
Months="3"
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

Vyanga (Facial Melanosis) is a skin disorder characterized by dark spots and hyperpigmentation due to an imbalance in Pitta Dosha. Modern lifestyle factors such as stress, sun exposure, hormonal changes, and poor skincare contribute to its prevalence. Ayurvedic treatments focus on detoxification and Pitta pacification, with herbal remedies showing potential in skin rejuvenation.

Shatadhauta Ghrita, a purified form of ghee, is traditionally used in skin treatments. Manjistha (Rubia cordifolia) and Khadira (Acacia catechu) are known for their blood-purifying, anti-inflammatory, and antioxidant properties, making them ideal for managing Vyanga.

Objectives:

1. To prepare Manjistha and Khadira Yukta Shatadhauta Ghrita.

2. To evaluate its therapeutic potential.

3. To assess its efficacy in treating Vyanga through Lepan (topical application).

Methodology:

Study Type: Clinical study.

Participants: 15 individuals (18–50 years).

Preparation: Manjistha and Khadira are processed with ghee and purified through repeated washing (Shatadhauta).

Application: The prepared formulation is applied to the affected area for 2 hours daily over 30 days.

Assessment: Melasma severity index, skin tone improvement, and reduction in lesion size.

Expected Outcome:

Improvement in skin pigmentation, reduction in dark spots, and enhanced skin radiance, validating the efficacy of Ayurvedic herbal formulations in treating facial melanosis.