E-ISSN:2456-3110

Research Protocol

Pharmaceutico-Analytical

Journal of Ayurveda and Integrated Medical Sciences

2025 Volume 10 Number 4 APRIL
Publisherwww.maharshicharaka.in

Study Protocol for Pharmaceutico-Analytical study and Clinical Evaluation of modified cream form of Sahachara Ghrita on Mukhdushika with special reference to Acne Vulgaris: A Randomized Controlled Trial

Uikey MS1*, Ramteke V2, Belge R3
DOI:10.21760/jaims.10.4.9

1* Manjusha S Uikey, Post Graduate Scholar, Department of Rasashastra and Bhaishajya Kalpana, Shri Ayurved Mahavidyalaya, Nagpur, Maharashtra, India.

2 Vinod Ramteke, Associate Professor, Department of Rasashastra and Bhaishajya Kalpana, Shri Ayurved Mahavidyalaya, Nagpur, Maharashtra, India.

3 Raman Belge, Professor and HOD, Department of Rasashastra and Bhaishajya Kalpana, Shri Ayurved Mahavidyalaya, Nagpur, Maharashtra, India.

Background: Mukhadushika/Acne vulgaris is a common chronic inflammatory condition of the skin. It is a prevalent issue affecting approximately 80% of teenagers and young adults.[1] Sahachara Ghrita is mentioned in Bhaishajyaratnavali for Mukhadushika.[2] To address the challenges of applying Sahachara Ghrita, a cream formulation is being developed for easier and more convenient application.[3]

Aim: To evaluate the pharmaceutico-Analytical study and clinical effect of modified cream form of Sahachara Ghrita on Mukhdushika with special reference to Acne vulgaris.

Materials and Methods: Sahachara Ghrita will be prepared as per classical reference. Modified cream form Sahachara Ghrita will be prepared as per texts. The prepared formulation will be assessed with organoleptic characters and physicochemical parameters. Clinical study will be carried out in 2 groups with modified cream form of Sahachara Ghrita and standard drug Shalmali Kantakadi Lepa respectively. They will be evaluated for their results on Mukhadushika.

Result: The analytical parameters will be assessed to establish pharmaceutical standardization. The result of clinical study will be drawn from the mentioned assessment criteria. Statistical analysis will be done accordingly.

Conclusion: If significant positive results are obtained in this work, then it will be a valuable contribution and evidence that the drug modified cream form Sahachara Ghrita is effective in Mukhadushika.

Keywords: Mukhadushika, Acne vulgaris, Sahachara Ghrita, Modified cream.

Corresponding Author How to Cite this Article To Browse
Manjusha S Uikey, Post Graduate Scholar, Department of Rasashastra and Bhaishajya Kalpana, Shri Ayurved Mahavidyalaya, Nagpur, Maharashtra, India.
Email: 		Uikey MS, Ramteke V, Belge R, Study Protocol for Pharmaceutico-Analytical study and Clinical Evaluation of modified cream form of Sahachara Ghrita on Mukhdushika with special reference to Acne Vulgaris: A Randomized Controlled Trial. J Ayu Int Med Sci. 2025;10(4):55-63.
Available From
https://jaims.in/jaims/article/view/4255/

Manuscript Received Review Round 1 Review Round 2 Review Round 3 Accepted
2025-03-15 2025-03-27 2025-04-07 2025-04-17 2025-04-27
Conflict of Interest Funding Ethical Approval Plagiarism X-checker Note
None Nil Yes 11.31

© 2025 by Uikey MS, Ramteke V, Belge R and Published by Maharshi Charaka Ayurveda Organization. This is an Open Access article licensed under a Creative Commons Attribution 4.0 International License https://creativecommons.org/licenses/by/4.0/ unported [CC BY 4.0].

J Ayu Int Med Sci 2025;10(4)55
Download PDFBack To ArticleIntroductionAim and ObjectivesMaterials and MethodsObservations and ResultsDiscussionConclusionReferences
Manjusha SU et al. Pharmaceutico-Analytical study and Clinical Evaluation

Introduction

Mukhadushika is one of the most prevalent skin diseases. Mukhadushika is categorized as one of the types of “Kshudraroga”.[4] Mukhadushika commonly manifests during the puberty stage, that’s why it's also termed as Yauvanpidika[5] or Tarunyapitika.

In modern science, it can be correlate with Acne vulgaris. Mukhadushika is a disorder in which papules resemble into Shalmali thorn-like lesions on the face due to vitiated Khapa, Vata Dosha, and Rakta Dhatu.[6,7]

Samanya Hetu

1. Kalaja - Yuva-Avastha (Young age)
2. Aharaja

A. Excess consumption of Katu, Tikta, Amla, Lavana Rasa
B. Snigdha, Ushna, Tikshna Ahar.

3. Viharaja - Atapasevana.
4. Manasika - Atikrodha, Atichinta, Atibhaya,Svabhava.

Samprapti

Hetu Sevana
↓
Vata and Kapha Dosh Prakop
Rakta Dushti
↓
Vishamata in Rasa-Rakta Dhatvagni.
↓
Meda Sanga in Romakupa of Mukhapradesh
↓
Mukhadushika

Samprapti Ghatak

1. Dosha - Vata & Kapha
2. Dhatu - Rakta
3. Agni - Vishamata in Rasa-Rakta Dhatvagni
4. Srotas - Raktvaha (mainly),
5. Srotodusti Prakara - Sanga.
6. Adhisthana - Mukhapradesh
7. Sthana Samshraya - Medogranthi of Mukhapradesh
8. Roga Marga - Bahyantara
9. Pratyatmakal Lakshana - Shalmali Kantaka like Pidika

(A cone-shaped eruption on the face, similar to Shalmali Kantaka is known as Mukhadushika)

There is considerable scope for additional clinical trials from both modern dermatological and Ayurvedic perspectives to deepen our understanding of Mukhdushika and its management.

For Mukhadushika, treatment is as described:

1. Nidanparivarjan
2. Shodhan Chikitsa
3. Shaman Chikitsa

A. Antahparimarjan Chikitsa (internal medication)
B. Bahirparimarjan Chikitsa (Topical applications)

e.g. Abhyanga (oil or Ghrita massage) e.g. Sahachara Ghrita (intervention)[2]

Lepas e.g. Shalmali Kantak Lepa[8,9] (control group)

Need of study

In Ayurveda, Sahachara Ghrita is mentioned in Bhaishajyaratnavali for Mukhadushika. Studying the modified cream form of Sahachara Ghrita validates its traditional usage and promotes its integration into treatment modalities for acne. To address the challenges of applying Sahachara Ghrita, a cream formulation is being developed for easier and more convenient application.

Creams

Creams are semi-solid or viscous liquid emulsions, either of water-in-oil or oil-in-water type, whose consistency varies according to proportions of water and oil. Modified cream form of Sahachara Ghrita is categorized in Water in oil (w/o) type of cream.

Nature of the knowledge gap identified

Table 1: Nature of the knowledge gap identified

Research Gap TypesType of research gap used
Knowledge GapThere is no previous work done on effectiveness of modified cream form of Sahachara Ghrita on Mukhadushika.
Methodological GapAfter extensive literature search, the research scholar could not find any clinical study of modified cream form of Sahachara Ghrita
Practical knowledge GapThere are conflicting results regarding the pharmaceutical and analytical observations of the stated drugs.
Empirical knowledge gapThe insufficient literature regarding conceptual, pharmaceutical, analytical and clinical studies has formed an empirical knowledge gap.

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Aim and Objectives

Aim: To evaluate the Pharmaceutico-Analytical study and clinical effect of modified cream form of Sahachara Ghrita on Mukhdushika with special reference to Acne vulgaris.

Objectives
Primary objectives

1. To prepare Sahachara Ghrita and its cream.
2. To analyse organoleptic & physico-chemical para. of Sahachara Ghrita, its modified cream form.
3. To compare the effect of modified cream form Sahachara Ghrita and Shalmali Kantakadi Lepa.

Materials and Methods

Present work will be conducted under foll. headings.

1.1 Pharmaceutical Study: In this study, Sahachara Ghrita will be prepared as per classical reference to establish pharmaceutical standardization. This pharmaceutical study will be done according to the following steps.

A) Selection of Raw material
B) Procurement of raw drugs - All raw drugs will be collected/procured from the field and authentic reliable sources.
C) Authentication of raw material - All raw materials will be verified and authenticated.

A) Pharmaceutical:

1. Sahachara Ghrita: It contain foll. ingredients

Sneha Draya: Goghrita[10-12]

Kwatha Dravya

Table 2: Kwatha Dravya

SNIngredientBotanical NamePart Used
1.Sahachara[13-15]Barleria prionitisPanchang
2.Shirisha [16-19]Albizia lebbeckTwak
3.Dashmoola[20]
a.Bilva [21,22]Aegles marmelosroot
b.Agnimanth[23]Premna serratifoliaRoot
c.Syonak(24]Oroxylum indicumRoot
d.Kashmari[25]Gmelina arboreaRoot
e.Patla [26]Stereospermum suaveolensRoot
f.Bruhati[27]Solanum indicumRoot
g.Kantakari [28]Solanum surattenseRoot
h.Gokshur[29]Tribulus terrestrisRoot
i.Shaliparni[30]Desmodium gangeticumRoot
j.PrushniparniUraria pictaRoot

Kalka Dravya

Table 3: Kalka Dravya

SNIngredientBotanical NamePart Used
1.Pippali [31]Piper longumFruits
2.Pippalimul [32]Piper longumRoot
3.Chavya [33]Piper retrofractumRoots, Fruit
4.Chitrakmul [34]Plumbago zeylanicaRoot
5.Sunthi [35]Zinziber officinaleRhizome
6.Vidang [36]Embelia ribesFruit
7.Saindhav [37]SodiI chloridum
8.Sauvarchalavan [38]Sodii muras
9.Samudralavan [39]
10.Bidlavan [40]Sal nigrum indicum
11.Tankan [41]Borax or Bicarbonate of soda
12.Swarjik Kshar [42]Caroxylones botidum
13.Yavakshar[43]Hordeum vulgare
14.Vrishchikali [44]Tragia involucrata
15.SindurRed oxide of mercury
16.Gairik [45]Ochre

Abhav Pratinidhi Dravya[46]

In present reference for Sahachara Ghrita, Audbhida Lavan is an ingredient. But it is not available.

When any Lavana is not available, Saidhava is used at its place. [47]

Preparation of Sahachara Ghrita

  • Collection of raw material.
  • Ghrita Murcchana will be carried out according to the texts.
  • Sahachara Panchanga, Dashamoola, and Shirisha Tvak will be coarsely powdered separately and soaked overnight in separate vessels. The next morning, each drug will be boiled separately over Mandagni until one-fourth of the original quantity remains, and then filtered through a clean cotton cloth.
  • All the ingredients mentioned in Kalka Dravya [from Pippali to Gairik] will be crushed into a fine powder and mixed with water to make a Kalka.
  • Go-ghrita will be taken in a vessel and heated slightly over Mandagni. Then, the Kalka and above three Kwathas will be added subsequently to the Ghrita and heated to prepare Paka until the Sneha Siddha Lakshaņas are attained. Afterward, the vessel will be taken out from the fire, and the Ghrita will be filtered.

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  • Finally, it will be stored in steel containers.

Preparation of cream

Table 4: Content of cream

SNExcipientsCategory
1.Bees waxBase
2.Liquid paraffinEmollient
3.BoraxEmulsifying agent
4.Methyl parabenPreservatives
5.Distilled water
6.Sahachara Ghrita

Method of preparation of cream

1. Oil phase

A) Liquid paraffin and beeswax will be added into one beaker, and the mixture will be heated.
B) Sahachara Ghrita will then be added to the oil phase beaker.

2. Aqueous phase

C) Borax will be taken and dissolved in distilled water in another beaker [aqueous phase].
D) The aqueous phase will be slowly added to the oil phase.
E) The mixture will be stirred vigorously until it forms a smooth cream.
F) A preservative will be added.
G) The cream will then be poured into a container.

2. Shalmali Kantakadi Lepa[8]

A) The Shalmali Kantak will be collected.
B) The drug will be cleaned and dried.
C) They will be powered by pounding with a mortar and pestle.

B) Analytical study

Analytical study of Sahachara Ghrita

Organoleptic Characters

  • Shabda [Sound]
  • Sparsh [Sensation]
  • Rupa [Colour]
  • Rasa [Taste]
  • Gandha [Odor]

Objective parameters of the Sahachara Ghrita

Physico-Chemical Parameters

  • Refractive index
  • Specific gravity

  • Acid value
  • Saponification value
  • Iodine value
  • Peroxide value

Analytical study of modified cream form of Sahachara Ghrita

Physico-chemical parameter of modified cream form of Sahachara Ghrita

  • pH
  • Viscosity
  • Acid value
  • Specific gravity
  • Spread ability
  • Rancidity

Organoleptic Characters of modified cream form of Sahachara Ghrita

  • Shabda
  • Sparsha
  • Rupa
  • Rasa
  • Gandha

C) Experimental Study

1. Assessment for eligibility.
2. Randomization.
3. Allotment of trial Group A and trial Group B.
4. Trial Group - A will receive modified cream form of Sahachara Ghrita and Trial Group - B will receive Shalmali Kantak Lepa
5. Intervention for 30 days.
6. Individual follow-up of trial group A and B will be done 0 th, 15th, 30th and 45th day.
7. Final analysis after completion of trial.
8. Conclusion and Result.

Inclusion criteria

1. Age group 18-30 years irrespective of gender.
2. Patient having symptom of Mukhadushika

  • Shalmali Kantak like eruptions.
  • Saruja Pidika (painful acne)
  • Ghana Pidikas (hard and thick acne)
  • Medogarbha Pidikas (acne filled with oil/sebum/pus)

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  • Shotha (Inflammation)

3. Patient having symptom of acne vulgaris

  • Open comedones (White head)
  • Close comedones (black heads)
  • Papule
  • Pustule.

Exclusion criteria

1. Patient suffering from any other skin disease and any allergic condition.
2. Patients of severe acne having inflammatory cyst.
3. Patients having hormonal imbalance like PCOD etc.
4. Genetic disorders

Withdrawal criteria

1. Patient willing to discontinue trial.
2. If patient develops any allergy due to study drug.
3. Inter current illness.

Sample size

Sample size in present study will be 30 for each group thus total 60 will be estimated sample size for this study.

Table 5: Sample Size

Group – AGroup – B
No. of patients3030
DrugModified cream form of Sahachara GhritaShalmali Kantak Lepa
DoseQuantity sufficientQuantity sufficient
Route of AdministrationLocal application (face)Local application (face)
Intervention30 days30 days
Duration of study45 days45 days
Follow-up0th, 15th, 30th & 45th days.0th, 15th, 30th & 45th days.

Subjective Criteria

Table 6: Subjective Criteria

SNSymptoms0th day15th day30th day45th day
1.Saruja (pain) Pidika
2.Pidika with Shotha
3.Ghana Pidika

Objective Criteria

Table 7: Objective Criteria

SNParameter0th day15th day30th day45th day
1.No. of Pidika
2.Medogarbha Pidikas (acne filled with oil/sebum/pus)
3.Open comedones (White head)
4.Close comedones (black heads)
5.Papule
6.Pustule
7.Nodules
8.Scarring

Grading scale

Table 8: No. of Pidika

SNNo. of PidikasGrade
1.No Pidika0
2.1-5 Pidikas1
3.5-10 Pidikas2
4.10-15 Pidikas3
5.More than 15 Pidika4

Table 9: Medogarbha

SNMedogarbhaGrade
1.No Pidaka containing fat inside0
2.1- 5 Pidaka containing fat inside1
3.5- 10 Pidaka containing fat inside2
4.10 - 15 Pidaka containing fat inside3
5.More than 15 Pidaka containing fat inside4

Table 10: Closed comedones

SNClosed comedones (white heads)Grade
1.No Closed comedones in area0
2.1- 5 Closed comedones in area1
3.5- 10 Closed comedones in area2
4.10- 15 Closed comedones in area3
5.More than 15 Closed comedones in area4

Table 11: Open comedones

SNOpen comedones (black heads)Grade
1.No open comedones in area0
2.1- 5 open comedones in area1
3.5- 10 open comedones in area2
4.10- 15 open comedones in area3
5.More than 15 open comedones in area4

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Table 12: Papules

SNPapulesGrade
1.No papules in area0
2.1- 5 papules in area1
3.5- 10 papules in area2
4.10- 15 papules in area3
5.More than 15 papules in area4

Table 13: Pustules

SNPustulesGrade
1.No Pustules in area0
2.1- 5 Pustules in area1
3.5- 10 Pustules in area2
4.10- 15 Pustules in area3
5.More than Pustules in area4

Table 14: Nodules

SNNodulesGrade
1.No Nodules in area0
2.1- 5 Nodules in area1
3.5- 10 Nodules in area2
4.10- 15 Nodules in area3
5.More than Nodules in area4

Investigator's Global Assessment [IGA] of acne severity

Table 15: Investigator's Global Assessment (IGA) of acne severity

0Clearerythema may be present
1Almost clearA few scattered comedones and a few small papules
2MildEasily recognisable; less than half the face is involved. Some comedones and some papules and pustules
3ModerateMore than half the face is involved. Many comedones, papules and pustules. One nodule may be present
4SevereEntire face is involved, covered with comedones, numerous papules and pustules, and few nodules and cysts

Criteria for assessment

Table 16: Criteria for assessment

Unchanged0 to 25% improvement
Mild26 to 50% improvement
Moderate51 to 75% improvement
Marked76 to 100% improvement

Statistical analysis

Data will be coded and analysed with the statistical software, STATA, version 10.1 (2011) by StataCorp, Texas, USA.

Methods

1. Study design: Pharmaceutical, Analytical, Experimental
2. Study period: 18 months study
3. Study centers: Present work will be conducted at the following study centres.

A) Pharmaceutical work will be carried out at the department of Rasashastra & Bhaishajya Kalpana of our Institute.
B) Analytical work will be carried out at certified Analytical laboratory.
C) A Clinical study will be carried out in the OPD of the Study centre.
D) We will approach other institutes as per need of study.

Statistical analysis:

1. Results will be expressed in mean value and standard error of the mean
2. Statistical analysis will be applied accordingly.

Observations and Results

Stepwise observations will be recorded and presented in the form of tables, charts and pictures, etc.

Discussion

Mukhadushika / Acne vulgaris is a common chronic inflammatory condition of the skin. It is a prevalent issue affecting approximately 80% of teenagers and young adults.

Acne can lead to significant psychological impact, so there is a need to find efficient treatments that can improve patient quality of life.

Ayurveda offers a reliable and efficient alternative for treating acne vulgaris.

Traditional medicine validation: Sahachara Ghrita is mentioned in Bhaishajya Ratnavali for Mukhadushika. Studying the modified cream form of Sahachara Ghrita validates its traditional usage and promotes its integration into treatment modalities for acne.

Treatment efficacy: Understanding the effectiveness of modified cream form of Sahachara Ghrita can offer valuable insight into its potential as a treatment option To address the challenges of applying Sahachara Ghrita,


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a cream formulation is being developed for easier and more convenient application.

Conclusion

The present study is planned to study the advancement of Ghrita form into cream. This a genuine attempt to fill the gap of few scientific evidences available and if significant positive results are obtained then it will be a valuable contribution and evidence that modified cream form of Sahachara Ghrita are as effective as in Mukhadushika.

Scope of study:

  • The positive outcome of the study will give the evidence that the Modified cream form of Sahachara Ghrita is more effective than Shalmali Kantak Lepa.
  • Possibility of other outcome Shalmali Kantak Lepa is more effective than Modified cream form of Sahachara Ghrita.
  • The difference in the outcome with reference to both the drugs will offer a light on the effectiveness of Modified cream form of Sahachara Ghrita in Mukhadushika.
  • If the Shalmali Kantak Lepa is more effective, then Shalmali Kantak Lepa will remain in practice.
  • With the positive outcome of Modified cream form of Sahachara Ghrita, further clinical studies can be conducted on a larger population.

Consent: Consent form will be signed from the subjects before start of study.

Ethical approval: Ethical approval will be taken from the Institutional Ethical Committee at our Institute.

Competing Interests: No competing interests exist.

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