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CTRI Number

CTRI/2023/05/052670 [Registered on: 16/05/2023] Trial Registered Prospectively

Last Modified On:

15/05/2023

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug
Ayurveda

Study Design

Randomized, Parallel Group Trial

Public Title of Study

Effect of majuphala in the management of pimples.

Scientific Title of Study

Randomized clinical trial of majuphala (Galls of Quercus infectoria Roxb.)lepa in mukhadushika (Acne vulgaris)-A clinical study

Trial Acronym

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Somya Watts
Designation	PG Scholar
Affiliation	NATIONAL INSTITUE OF AYURVEDA
Address	Department of dravaguna vigyana, National institute of ayurveda,Deemed to be university (De-novo)Jorawar singh gate ,amer road ,jaipur rajasthan 302002 india Department of dravyaguna vigyana National institute of ayurveda,Deemed to be university (De-novo)Jorawar singh gate ,amer road ,jaipur rajasthan 302002 india Jaipur RAJASTHAN 302002 India
Phone	7073654920
Fax
Email	wattssomya7.sw@gmail.com

Details of Contact Person
Scientific Query

Name	ProfMita Kotecha
Designation	Prof and HOD(Dravyaguna department),Pro VC,Dean UG
Affiliation	National institute of ayurveda
Address	National institute of ayurveda National institute of ayurveda,Deemed to be university (De-novo)Jorawar singh gate ,amer road ,jaipur Jaipur RAJASTHAN 302002 India
Phone	9414078872
Fax
Email	mita@ayu.in

Details of Contact Person
Public Query

Name	Somya Watts
Designation	PG Scholar
Affiliation	NATIONAL INSTITUTE OF AYURVEDA
Address	Department of Dravyaguna Vigyana National institute of Ayurveda,Deemed to be university (De-novo)Jorawar singh gate ,amer road ,jaipur Department of Dravyaguna Vigyana, National institute of Ayurveda,Deemed to be university (De-novo)Jorawar singh gate ,amer road ,jaipur Jaipur RAJASTHAN 302002 India
Phone	7073654920
Fax
Email	wattssomya7.sw@gmail.com

Source of Monetary or Material Support

National institute of ayurveda deemed to be university jaipur rajasthan.

Primary Sponsor

Name	National institute of ayurveda department jaipur,Rajasthan
Address	National institute of ayurveda department jaipur,Rajasthan
Type of Sponsor	Research institution and hospital

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
DrSomya Watts	National institute of ayurveda	National institute of ayurveda,(De-novo),jorawar singh gate amer road,jaipur 302002 Jaipur RAJASTHAN	7073654920 wattssomya7.sw@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional ethics commiittee of ayurveda deemed to be university	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition:L700\|\|Acne vulgaris. Ayurveda Condition: YUVANAPIDAKAÂ (MUKHADUSHIKA),

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Comparator Arm	Drug	Classical		(1) Medicine Name: majuphala, Reference: à¤µà¥ˆ. à¤µà¤²à¥à¤²à¤à¥¤à¤µà¤¿. à¥, Route: Topical, Dosage Form: Lepa Churna, Dose: 15(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -water), Additional Information: -
2	Intervention Arm	Drug	Classical		(1) Medicine Name: majuphala, Reference: à¤µà¥ˆ. à¤µà¤²à¥à¤²à¤à¥¤à¤µà¤¿. à¥, Route: Topical, Dosage Form: Lepa Churna, Dose: 15(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -rice water), Additional Information: -

Inclusion Criteria

Age From	18.00 Year(s)
Age To	40.00 Year(s)
Gender	Both
Details	1. Patients presenting with signs and symptom of Mukhadushika were selected. 2. Patients of the age group between 18-40 years were selected irrespective of sex and economical status. 3. Acne vulgaris specific on face.

ExclusionCriteria

Details

1.The age group < 18 years and > 40 years.

2. Mukhadushika with other diagnosed skin disorder etc were excluded.

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Sequentially numbered, sealed, opaque envelopes

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
Relief in Pimples.	30 DAYS

Secondary Outcome

Outcome	TimePoints
Skin tightening, De pigmentation	30 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 2/ Phase 3

Date of First Enrollment (India)

30/05/2023

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

30/05/2023

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

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary

According to Ayurveda healthy skin is a result of overall health condition of an individual. The face is the feature which distinguishes a person. It is one of the essential parameter for oneâ€™s personality and appearance. The concern of face has taken first place in this present time. If it gets any anamoly, it lowers down the confidence of an individual as each and every one wants to look beautiful.

Cosmetology is the science dealing with beautification and having certain definite principles. People are using cosmetics not only for curing their skin problems but in routine to maintain the skin appearance and beauty.

Mukhadushika is the most common disease and usually self-limiting condition of teenager and adults. It is described in the kshudraroga chapter by Acharya sushruta which is caused by vitiation of kapha, vata, rakta which appear on face like a shalmali thorn, so called as yuvanapidika / tarunyapidika also due its prevalence in youth¹. It is the nearest entity for acne vulgaris. Although itâ€™s not a serious threat to the general health, but the social, psychological and emotional impact of acne makes it a disease for the concern.

Acne vulgaris is a chronic inflammatory disease of pilo sebaceous follicles characterised by comedons, inflamed pustules , papules and nodules². There are various factors responsible for acne like hormonal changes, stress, diet, pollution etc. It manifests because of physiological disturbances during puberty. This is common illness affecting 80% of adolescents during puberty. It affects females more as puberty occurs early in females³. In 2010, acne was estimated to affect 650 million people globally making it the 8th most common disease worldwide⁴

There are ample of formulations available for Mukhadushika(Acne), butinstead of using complex formulation ,single drug formulation may be more feasible and effective. Majuphala,due to its easy availability and cheaper cost may be the most effective drug to treat Mukhadushika along with itâ€™s aided benefits like antiageing, skin tightening etc. Also, According to Nighantu Adarsh, it is uttamstambak, shleshmnashak, shonitsthapana, and vishaghna^5.

Galls arise on young branches of Quercusinfectoria tree⁶and contains the highest naturally occurring level of tannin (approx 50-70%)⁷. Tannins have been used for hundreds of years for medical purposes and are currently indispensible in dermatology⁸. Tannins are natural astringent which makes it best anti-oxidant, antibacterial⁹ , anti-inflammatory¹⁰ thus reduces inflammation and tightens pores and therefore reduces acne.