Effectiveness Of Nasya of Kumkumadi Ghrita And Majuphaladi Lepa in Acne vulgaris

Phase 2

Not yet recruiting

• Conditions: Acne vulgaris. Ayurveda Condition: YUVANAPIDAKAÂ (MUKHADUSHIKA),

• Registration Number: CTRI/2023/04/051470
• Lead Sponsor: State Ayurvedic College And Hospital Lucknow

Brief Summary

The synopsis entitled as:

“***A Comparative clinical study to evalutate theeffectiveness of Majuphaladi lepa with and without kumkumadi ghrita nasya inthe management of Mukhadushika (with special reference to Acne vulgaris)â€***

*Need Of Study*

Ø Nowdays people are more conscious regarding their facialmagnificence specially youngesters and they are expecting management fromnatural resources like herbs,minerals and other measures of Ayurveda.

Ø Patients of mukhadushika are morelikely to have low selfsteem,embarrassment,school avoidance and socialinstability.The consequences can be devastating leading toanxiety,deression,obsessive compulsive behaviour.Thus it causes significanteffect on quality of life(QoL).

Ø Although different ayurvedicpreparations for topical(local )use has been researched majorly formukhadushika but internal formulations are still very less exploredspecially  nasya therapy one of the mostimportant panchkarma shodhan procedures which shows local as well as systemiceffects.

Ø The measures provided by contemporaryscience has revolutionized the treatment but it’s manyfold side effects andtemporary reliefs are limitations to therapy so course of disease becomechronic with frequent exacerbations and remessions.Due to irrational and extensiveuse of several multidrug resistant strains of micobes are developing.

Ø Till now no study has been carriedout on mukhadushika using Majuphaladi lepa (locally) & Kumkumadi ghritanasya(internally) as per best of my knowledge.

All thesefactors necessitate for surge of another alternative ayurvedic management toovercome above concerns.

***Research Question***

Research Question-Is Kumkumadi ghrita pratimarsh nasyaand Majuphaladi lepa are effective in management of Mukhadushika (Acnevulgaris)?

***Study Objective***

**Cardinal objective**

1)To evaluate the efficacy of Majuphaladi lepalocally &Kumkumadi ghrita through nasal route in the management of lesionof mukhadushika (Acne vulgaris).

2)To compare the results of both trial group A&B .

**Ancillary objective**

1)To reveal,interpret the conceptual aspect ofmukhadushika (Acne vulgaris )in Ayurvedic and modern literature both.

2)To collect,classify,analyse the relevant contents fromAyurvedic texts,research paper, contemporary modern texts & authenticwebsites.

3)To assess the safety,pliability and compliance of thetrial drug for the patients

***Plan of Study***

Type of study : Phase2,Rational,Open,Randomized & Parallel group study

v   Duration of trial: 60 days

v  Follow up during treatment:15th,30th,45th&60th day

v Follow up after treatment: after 15days (without the drug)

v Sample size : Minimum 60 patients ofhaving classical signs of mukhadushika w.s.r to Acne vulgaris will be selectedfrom OPD of state ayurvedic college &Hospital on the basis of inclusion andexclusion criteria  (approximately 5%drop out)

v Number of groups-Patients arerandomly (sequential)allocated into 2 groups A&B.

v Settings: P.G.Deptt.ofKayachikitsa,SAC&Hospital,Lucknow

**Regimen under trial**

Majuphaladilepa-majuphal churna mixed with tandulodaka

KumkumadiGhrita-

containskesar(Kumkum),Haridra,Daruharidra,Pippali,Chitraka & Goghrita

*Group A  :* kumkumadighrita(lukewarm) pratimarsh nasya 2drops in each nostril twice in a day morningand evening before meal **+** Majuphaladi lepa thickness of 1/4thof a finger(approx. 4-5mm) mixed with tandulodaka for a minimum period of untilit dries up(approx.1/2 an hour)

*Group B :* Majuphaladilepa thickness of 1/4th of a finger(approx. 4-5mm) mixed withtandulodaka for a minimum period of until it dries up(approx.1/2 an hour

Area-depends on intensity & severity of acnelesions

***Inclusion Criteria***

v Patientvoluntarily willing to participate in the trial.

v Patientwith age between 16-35 years .

v Patientwho have signs and symptoms of mukhadushika/Acne vulgaris as per ayurvedictext.

v Bothfresh and treated cases of of mukhadushika/ acne vulgaris will be selected.

v Patientwill be selected irrespective of sex, religion,education,area &socioeconomic status.

***Exclusioncriteria***

v Patientshaving pidika of other kshudra rogas and kustha rogas.

v Anyknown sensitivity to the contents of trial drugs

v Agegroup less than 16 years and more than 35years .

v Pregnant  and lactating women.

v Peoplewho are suffering from uncontrolled metabolic &  systemic disorder-Adrenal tumour,chronicliver and renal diseases, ,Diabetes mellitus,malignancy and immuno-compromisedpeople.

***Subjective parameters***

According toSushrut Nidan sthana 13/38 , A.H.Uttar tantra 31/5 & Charak Sutrasthana18/24

EssentialCriteria

v  Pidika resembling to shalmali kantaka on face

v Ghana(thick/indurated/hard)

v Medogarbha(comedones-impregnatedwith meda/sebum/oil)

v Saruja(pain-mild/ acute)

v Saraga(erythema)

Non-essential Criteria

v Daha(burningsensation)

v Shopha(swelling)

v Scar

v Srava(Discharge)

v Kandu(Itching)

v Paka(suppuration)

**Objectivecriteria**

According toGlobal Acne Grading System(GAGS)

**Outcome Assessment Parameters:**

1)MarkedImprovement

§  >75% relief in terms of subjectivecriteria

§  Objective criteria upto normal range

§  No reoccurrence of new pidika uptofollow up period

2)ModerateImprovement

§  Patients having improvement between51-75% in terms of subjective & objective criteria

§  No reoccurrence of pidika upto followup period

3)Mildimprovement

§  Patients having improvement between26-50% in terms of subjective & objective criteria

§  Pidika may be reoccurring

4)Unchanged/Notimproved

§  Patients having 25% reliefs in termsof subjective & objective criteria

§  Pidika may be reoccurring

5)Worsened

§  No relief in terms of objective &subjective parameters

§  Increase in no.of pidika,shopha,daha,depigmentation of skin or any other complication

**Conclusion & Statistical Analysis**

Interpretation(effectivenessof trial drugs& comparison of both the groups) will be based on accordingto data collected.

Allinformation collected from clinical study will be presented in the forms oftable, graph,diagram and charts( by using standard statistical method)

**EthicalAspect-** Informed andwritten consent will be taken from every patient after giving them informationabout proposed effect of trial drug.Ethical norms & standards by National and international authoritiesrelated to human trials will be followed.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-05
• Last Update Posted: 2023-10-04

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 1)Patient voluntarily willing to participate in above mentioned trial.
• 2)Patient with age between 16-35 years old.
• 3. Patient who have signs and symptoms of mukhadushika/Acne vulgaris as per ayurvedic text.
• 4)Both fresh and treated cases of of mukhadushika/ acne vulgaris will be selected.

Exclusion Criteria

• 1)Patients having pidika of other kshudra rogas and kustha rogas.
• 2)Any known sensitivity to the contents of trial drugs 3)Age group less than 16 years and more than 35years .
• 4)Pregnant and lactating women.
• 5. People who are suffering from uncontrolled metabolic & systemic disorder-Adrenal tumour,chronic liver and renal diseases,Hypertension,Diabetes mellitus,malignancy and immuno-compromised people.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Saruja(pain-mild	D0,D15,D30,D45,D60
/acute)	D0,D15,D30,D45,D60
Pidika resembling shalmali kantaka on face(eruption like shalmali thorns on face)	D0,D15,D30,D45,D60
Ghana(thick/indurated)	D0,D15,D30,D45,D60
Medogarbha(impregnated with meda/sebum/oil)	D0,D15,D30,D45,D60
Saraga	D0,D15,D30,D45,D60
/erythema	D0,D15,D30,D45,D60

Secondary Outcome Measures

Name	Time	Method
Daha(burning sensation)	Shopha(swelling)

Trial Locations

Locations (1)

State Ayurvedic College And Hospital Turiyaganj Lucknow; 🇮🇳 Lucknow, UTTAR PRADESH, India

State Ayurvedic College And Hospital Turiyaganj Lucknow

🇮🇳Lucknow, UTTAR PRADESH, India

Dr Aparana Pathak

Principal investigator

8851198544

aparanap322@gmail.com