1. What data in particular will be shared?
   Response - All of the individual participant data collected during the trial, after de-identification.
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   
   
3. Who will be able to view these files?
   Response - Researchers who provide a methodologically sound proposal.
   


4. For what types of analyses will this data be available?
   Response - To achieve aims in the approved proposal.
   


5. By what mechanism will data be made available?
   Response - Proposals should be directed to [aparanap322@gmail.com].
   


6. For how long will this data be available start date provided 01-05-2023 and end date provided 01-05-2028?
   Response - Beginning 3 months and ending 5 years following article publication.
   


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - nil

The synopsis entitled as:

“A Comparative clinical study to evalutate the effectiveness of Majuphaladi lepa with and without kumkumadi ghrita nasya in the management of Mukhadushika (with special reference to Acne vulgaris)”

Need Of Study

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

Ø Patients of mukhadushika are more likely to have low selfsteem,embarrassment,school avoidance and social instability.The consequences can be devastating leading to anxiety,deression,obsessive compulsive behaviour.Thus it causes significant effect on quality of life(QoL).

Ø Although different ayurvedic preparations for topical(local )use has been researched majorly for mukhadushika but internal formulations are still very less explored specially  nasya therapy one of the most important panchkarma shodhan procedures which shows local as well as systemic effects.

Ø The measures provided by contemporary science has revolutionized the treatment but it’s manyfold side effects and temporary reliefs are limitations to therapy so course of disease become chronic with frequent exacerbations and remessions.Due to irrational and extensive use of several multidrug resistant strains of micobes are developing.

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

All these factors necessitate for surge of another alternative ayurvedic management to overcome above concerns.

Research Question

Research Question-Is Kumkumadi ghrita pratimarsh nasya and Majuphaladi lepa are effective in management of Mukhadushika (Acne vulgaris)?

Study Objective

Cardinal objective

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

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

 Ancillary objective

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

 2)To collect,classify,analyse the relevant contents from Ayurvedic texts,research paper, contemporary modern texts & authentic websites.

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

Plan of Study

 Type of study : Phase 2,Rational,Open,Randomized & Parallel group study

v   Duration of trial: 60 days

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

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

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

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

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

Regimen under trial

Majuphaladi lepa-majuphal churna mixed with tandulodaka

Kumkumadi Ghrita-

contains kesar(Kumkum),Haridra,Daruharidra,Pippali,Chitraka & Goghrita

Group A  : kumkumadi ghrita(lukewarm) pratimarsh nasya 2drops in each nostril twice in a day morning and evening before meal + Majuphaladi lepa thickness of 1/4^th of a finger(approx. 4-5mm) mixed with tandulodaka for a minimum period of until it dries up(approx.1/2 an hour)

Group B : Majuphaladi lepa thickness of 1/4^th of a finger(approx. 4-5mm) mixed with tandulodaka for a minimum period of until it dries up(approx.1/2 an hour

Area-depends on intensity & severity of acne lesions

Inclusion Criteria

v Patient voluntarily willing to participate in the trial.

v Patient with age between 16-35 years .

v Patient who have signs and symptoms of mukhadushika/Acne vulgaris as per ayurvedic text.

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

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

           Exclusion criteria

v Patients having pidika of other kshudra rogas and kustha rogas.

v Any known sensitivity to the contents of trial drugs

v Age group less than 16 years and more than 35years .

v Pregnant  and lactating women.

v People who are suffering from uncontrolled metabolic &  systemic disorder-Adrenal tumour,chronic liver and renal diseases, ,Diabetes mellitus,malignancy and immuno-compromised people.

Subjective parameters

  According to Sushrut Nidan sthana 13/38 , A.H.Uttar tantra 31/5 & Charak Sutra sthana18/24

  Essential Criteria

v  Pidika resembling to shalmali kantaka on face

v Ghana(thick/indurated/hard)

v Medogarbha(comedones-impregnated with meda/sebum/oil)

v Saruja(pain-mild / acute)

v Saraga(erythema)

Non-essential Criteria

v Daha(burning sensation)

v Shopha(swelling)

v Scar

v Srava(Discharge)

v Kandu(Itching)

v Paka(suppuration)

Objective criteria

According to Global Acne Grading System(GAGS)

   Outcome Assessment Parameters:

1)Marked Improvement

§  >75% relief in terms of subjective criteria

§  Objective criteria upto normal range

§  No reoccurrence of new pidika upto follow up period

2)Moderate Improvement

§  Patients having improvement between 51-75% in terms of subjective & objective criteria

§  No reoccurrence of pidika upto follow up period

3)Mild improvement

§  Patients having improvement between 26-50% in terms of subjective & objective criteria

§  Pidika may be reoccurring

4)Unchanged/Not improved

§  Patients having 25% reliefs in terms of 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(effectiveness of trial drugs& comparison of both the groups) will be based on according to data collected.

All information collected from clinical study will be presented in the forms of table, graph,diagram and charts( by using standard statistical method)

Ethical Aspect- Informed and written consent will be taken from every patient after giving them information about proposed effect of trial drug. Ethical norms & standards by National and international authorities related to human trials will be followed.