| CTRI Number |
CTRI/2025/10/096549 [Registered on: 28/10/2025] Trial Registered Prospectively |
| Last Modified On: |
27/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Valmika Mruttika (Clay) Face Pack with Shukrashodhan Mahakashay Churna in the Management of Acne (Mukhdushika) |
|
Scientific Title of Study
|
A Randomized Controlled Study On The Effect Of Valmika Mruttika ( Ant hill soil ) Lepa with Shukrashodhan Mahakashay Churna in Mukhdushika With Special Reference To Acne Vulgaris |
| 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 Harshal Himmatrao More |
| Designation |
MD Swasthavrittha Scholar |
| Affiliation |
Smt K C Ajmera Ayurved Mahavidyalaya Deopur Dhule |
| Address |
Department Of Swasthavritta Smt K C Ajmera Ayurved Mahavidyalaya Dayasagar Educational Campus Deopur Dhule Tal Dist dhule 424002 Maharashtra India
Dhule
MAHARASHTRA
424002
India |
| Phone |
9766976732 |
| Fax |
|
| Email |
harshalsai96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh Maganlal Shah |
| Designation |
MD Swasthavritta |
| Affiliation |
Smt K C Ajmera Ayurved Mahavidyalaya Deopur Dhule |
| Address |
Department Of Swasthavritta Smt K C Ajmera Ayurved Mahavidyalaya Dayasagar Educational Campus Deopur Dhule Tal Dist dhule 424002 Maharashtra India
Dhule
MAHARASHTRA
424002
India |
| Phone |
9372811149 |
| Fax |
|
| Email |
drrmshah@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajesh Maganlal Shah |
| Designation |
MD Swasthavritta |
| Affiliation |
Smt K C Ajmera Ayurved Mahavidyalaya Deopur Dhule |
| Address |
Department Of Swasthavritta Smt K C Ajmera Ayurved Mahavidyalaya Dayasagar Educational Campus Deopur Dhule Tal Dist dhule 424002 Maharashtra India
Dhule
MAHARASHTRA
424002
India |
| Phone |
9372811149 |
| Fax |
|
| Email |
drrmshah@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Swasthavritta Smt K C Ajmera Ayurved Mahavidyalaya Dayasagar Educational Campus Deopur Dhule Tal Dist dhule 424002 Maharashtra India |
|
|
Primary Sponsor
|
| Name |
Smt K C Ajmera Ayurved Mahavidyalaya Deopur Dhule |
| Address |
Department Of Swasthavritta Smt K C Ajmera Ayurved Mahavidyalaya Dayasagar Educational Campus Deopur Dhule Tal Dist dhule 424002 Maharashtra India |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Harshal Himmatrao More |
Smt K C Ajmera Ayurved Mahavidyalaya And Hospital Deopur Dhule |
Department Of Swasthavritta Smt K C Ajmera Ayurved Mahavidyalaya Dayasagar Educational Campus Deopur Dhule Tal Dist dhule 424002 Maharashtra India
Dhule
MAHARASHTRA |
9766976732
harshalsai96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L700||Acne vulgaris. Ayurveda Condition: PIDAKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Valmika Mruttika, Reference: Research Article, Route: Topical, Dosage Form: Lepa Churna, Dose: 5(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 28 Days, anupAna/sahapAna: No, Additional Information: -Nil | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Shukrashodhan Mhakashay Churna, Reference: Charak Samhita, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: -Jal), Additional Information: -Nil |
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients Of Age Group 18 To 30 Years Will Be Selected For Study 2. Both Male And Female Patients Having Sign And Symptoms Of Mukhdushika (Acne Vulgaris) Irrespective Of Their Socioeconomic Status Educational Status Caste And Religion 3.Patient Who Will Fullfill The Diagnostic Criteria Of Mukhdushika. |
|
| ExclusionCriteria |
| Details |
1.K/C/O Prameha pidika(Diabetic carbuncles), Masurika(German Measles), Blisters will be excluded
from the current study. 2.Patients who are using topical or systemic steroids or NSAIDs (for example, for pain or skin issues). 3. Clinically infected lesions that require systemic antibiotics, local antiseptics, or additional treatment. 4. Pregnant women or lactating mothers. 5. Known allergic condition. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Daha (Burning) Decreased
2.Shotha (Imflammation) Decreased
3. Vedana(Pain) Decreased |
14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Number of Pidika present on Nose, Forehead, Chick, Chin, Upper chest, Upper back Decreased
2. Area occupied by Pidika will be measure by Vernier Calliper (nose/forehead/chick/chin/upper chest/upper back) Decreased |
28 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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
07/11/2025 |
| 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="1"
Months="6"
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
|
In the present era, physical appearance carries a very important role as it is one of the factors
for a person to be fit. Mukhdushika (Youvan Pidaka) is a burning issue in the society. Though it
is not life-threatening, it causes psychological upset of worries to the person. Youvana Pidaka
as the name suggests is considered an adolescent disorder. People are more cautious about
outer looks and Youvana Pidaka makes one look unattractive.
Mukhdushika according to modern science is correlated with Acne vulgaris. Acne is a cutaneous
pleomorphic disorder of the Pilo- sebaceous glands involving abnormalities in sebum
production and is characterized by the formation of both inflammatory (papules pustules and
nodules) and no inflammatory lesions (open and closed come). It typically affects the face but
can also occur on the upper arm, trunk & back.
1
According to the Global Burden of Diseases (GBD) study Acne Vulgaris is a very prevalent
condition that affects 85% of the population and primarily appears during adolescence.
2 The
condition typically begins in adolescence and persists into thirties and forties.
3
In Modern
current medical treatment Acne vulgaris includes benzoyl peroxide. Antibiotics, Anti-seborrheic
medications, Sulphur and Sodium Sulpha-acetamide, anti-androgen, medications salicylic and
hormonal treatments, alpha hydroxy and retinoids, azelaic acid, keratolytic soaps, and
nicotinamide.
4
This drug gives temporary relief while causing a variety of adverse effects and Relapse occurs
when the medications are discontinued. So, there is a need to find out alternative source.
Mukhdushika which has a symptomatic Relationship with Acne vulgaris existed since the Vaidikera. So, in the Ayurvedic text, a detailed description of the management of Mukhdushika
has been mentioned. Acharya Sushruta mentioned in one of the 44 Kshudra Rogas there is a
formation of Pidaka on the face like Shalmali Kantaka (thorny) called Mukhdushika.
5
Acharya Sharangadhara also described Mukhdushika as Youvana Pidakamala (a waste
product)of Shukra Dhatu.
6AsAyurvedas entire clinical approach is centered on the preventative
promotional and curative aspect so Ayurveda can provide a better cure for ailment and tackle
the underlying causes. That’s why we are considering classical drugs stated in Ayurveda in the
treatment of Mukhdushika.
According to Aacharya Dalhana Shodhana of disease is done in two ways as follows
Antaparimarjan (Internal medication) and Bahiparimarja (external Application)
7
. So here we
selected the Valmiki Mruttika (ant hill soil) Lepa for Bahiparimarjan (external Application) as it
is very rich in protein that helps in rejuvenating the cells and growth of skin cells. Phenol, antioxidant, and tannins are found to have anti-acne and Varnya properties. Kashaya rasa
(Astringent) that acts on Kapha Dosha of Youvana Pidaka
8 and for Antaparimarjan
Shukrashodhan Mahakashayaa Churna selected. Because Aacharya Sharngdhara is described
as Mukhdushika are Mala of Shukradhatu
9
. So, if proper purification (Shuddhi) of Shukradhatu
is done then automatically there will be a decrease in the production of Mala means
Mukhdushika. That different way of thinking about Samprapti Bhanga (breakdown of Pathophysiology) is considered here.
|