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CTRI Number  CTRI/2025/03/083585 [Registered on: 27/03/2025] Trial Registered Prospectively
Last Modified On: 25/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Clinical study to study the efficacy of Jatiphaladi lepa and Lodhradi lepa along with Khadirashtak kwatha along with the management of Mukhadushika with special referance to Acne Vulgaris 
Scientific Title of Study   A Comparative clinical study to evaluate the clinical efficacy of Jatiphaladi Lepa and Lodhradi Lepa along with Khadirashtak Kwatha in the management of Mukhadushika with Special referance 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 Rakhi Anant Jadhav  
Designation  P G Scholar 
Affiliation  R.A Podar Ayu. medical college ,Worli Mumbai 400018 
Address  Kayachikitsa Department,R.A Podar Govt.(Ayu.)Medical college,M.A POdar hospital, Worli,Mumbai
Kayachikitsa Department,R.A Podar Govt.(Ayu.)Medical college,M.A Podar Hospital , Worli,Mumbai
Mumbai
MAHARASHTRA
400018
India 
Phone  8007545422  
Fax    
Email  rajanant651997@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Dilip Uttamrao Wange 
Designation  Associate Professor  
Affiliation  R.A.Podar Govt.(Ayu.)College Worli Mumbai 400018 
Address  OPD No. 18, Kayachikitsa Department,M.A Podar Govt.(Ayu.) hospital,R.A Podar Medical(ayu.) college Worli,Mumbai 400018
Kayachikitsa Department,R.A Podar Govt.(Ayu.)Medical College,M.A Podar Hospital,Worli,Mumbai 400018
Mumbai
MAHARASHTRA
400018
India 
Phone  9892323677  
Fax    
Email  drdilip.wange@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Dilip Uttamrao Wange  
Designation  Associate Professor  
Affiliation  R.A Podar Ayu.(Govt.) medical college ,Worli Mumbai 400018 
Address  Kayachikitsa Department,M.A Podar Govt.(Ayu.)hospital,R.A.Podar govt. Medical(Ayu.),Worli,Mumbai 400018
Kayachikitsa Department,M.A .Podar (Ayu.)Hospital,R.A Podar govt.medical college ,Worli,Mumbai 400018
Mumbai
MAHARASHTRA
400018
India 
Phone  9892323677  
Fax    
Email  drdilip.wange@gmail.com  
 
Source of Monetary or Material Support  
OPD No. 18 Kayachikitsa Department,M.A Podar Hospital, ,R.A Podar Govt.(Ayu.)Medical College,Dr Annie Besant Road ,Worli,Mumbai,Maharashtra, 400018,Country India.  
 
Primary Sponsor  
Name  R A Podar Govt Ayu Medical College Worli Mumbai  
Address  R.A Podar Govt.(Ayu.)Medical College,Worli,Mumbai 400018 
Type of Sponsor  Government medical college 
 
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 
Rakhi Anant Jadhav  Mahadevi Anandilal Podar Govt. Hospital  OPD No.18, Kayachikitsa Department, M.A Podar Govt. (Ayu)Hospital,R.A Podar Ayu. Govt. Medical College,Worli Mumbai 400018
Mumbai
MAHARASHTRA 
8007545422

rajanant651997@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
BORS Committee of Institution R.A Podar Govt.( Ayu) Medical College Worli Mumbai 400018  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: YUVAN, (2) ICD-10 Condition:L700||Acne vulgaris. Ayurveda Condition: YUVAN,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-lepa, लेप (Procedure Reference: Yogratnakar uttarardha Kshudrarogachikitsa adhyay, Procedure details: Duration once a day for 28 days Applied by mixing the lepa churna with water & applied wet ardhangula thickness & removed when not more dry not more wet.)
(1) Medicine Name: Lodhradi Lepa, Reference: Yogratnkar Uttarardha Kshudraroga chikitsa adhyay, Route: Topical, Dosage Form: Lepa Churna, Dose: 20(g), Frequency: od, Duration: 28 Days
2Intervention ArmProcedure-lepa, लेप (Procedure Reference: Sharangdharasamhita Uttar khanda Adhyay No.11, Procedure details: Applying once a day MIxed with water & adra lepa apllied ardhagula thickness over the sites of pimples and removed when not more dried and not more wet.)
(1) Medicine Name: Jatiphaladi lepa, Reference: lepa, Route: Topical, Dosage Form: Lepa Churna, Dose: 20(g), Frequency: od, Duration: 28 Days
3Comparator ArmDrugOther than Classical(1) Medicine Name: Khadirashtak Kwatha, Reference: NA, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  Patients having symptoms like Pitika over face,chest ,back And having Ruja.
Subjects who are willing to give written consent. 
 
ExclusionCriteria 
Details  The patients with the conditions like Acne Rosasea,Eczema,Steroid Induced Acne
patients with known case of Renal Impairement.
patients suffering from Autoimmune diseases (RA,SLE)
patients suffering from any life threatening disorders like Cancer,HIV etc.
patients with any undergoing Immunosuppressive treatment
pregnant and lactacting females
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Jatiphaladi lepa is more effective than ladhradi lepa along with khadirashtak kwatha in the management of Mukhadushika with special referance to Acne Vulgaris .
2. Lodhradi lepa is more effective than jatiphaladi lepa along with khadirashtak kwatha in the management of mukhadushika with special referance to acne vulgaris.

 
4 Weeks 
 
Secondary Outcome  
Outcome  TimePoints 
1. To Review the Ayurvedic & Modern literatue on Mukhadushika with special referance to Acne Vulgaris.

2. To evaluate the efficacy among jatiphaladi lepa & lodhradi lepa along with khadirashtak kwath in the management of mukhadushiaka with special referance to acne vulgaris.
 
At day 10th till 28th day 
 
Target Sample Size   Total Sample Size="88"
Sample Size from India="88" 
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 
Date of First Enrollment (India)   06/04/2025 
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="0"
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  


     Ayurveda being the most ancient science which believes in  three pillars, (vata,pitta and kapha )dosha , seven types of dushya and three types of Mala. The equilibrium state of normalcy of all the factors is considered as Swastha. If  one of these factor gets vitiated it creates disequilibrium with the swastha ,And when such vitiation occurs at specific part of the body or organ the symptoms are also observed with respect to  that part of the body or organ.

      In such a way when Vata,kapha and Rakta dushya gets vitiated, small or medium sized eruptions appear over the face it is  diagnosed as Mukhadusika ( Mukh =Face And Dushika means which causes disfigurement over the facial surface) and these appear mostly in adolescent young age ,hence mentioned as Tarunyapitika in  texts ( Acne Vulgaris) . Sometimes there may be meda accumulated inside the eruptions hence in Ashtang Hriday mukhadusika are described as Medogarbha[1], which looks like shalmali kantak hence the appearance of   mukhadusika are compared with shalmali kantak. [2]

Acne Vulgaris is most common disorder of Pilosebaceous glands which commonly affects the hair folicles found over the face[3]

Acne vulgaris mainly affects the age group of 15year to 30 years. 90% of Adolescent boys and 80-85% of adolescent Girls get affected with Acne Vulgaris[3] There are some endocrinological disorders also causing acne Vulgaris  (Hypothyroidism, PCOS in females, During menstruation in females due to surge of oestrogen hormone) and so on. 

There are some predisposing factors regarding Lifestyle, such as, Disturbed sleep, Consumption of junk, oily foods, etc. can cause acne over the face. Some environmental factors such as Hot and Humid Atmosphere can also aggravate the diasease. Moreover Excessive use of Cosmetic products, Oil based Local applications  causes acne over the face.

The presentation of Acne Vulgaris is mainly characterised in the form of Papules, pustules and Nodules( painful or painless).

In Ayurvedic texts, acne vulgaris is mentioned as Mukhadushika / Tarunyapitika and Medogarbha in which the Vatadosha, Kaphadosha and Rakta dushya are vitiated .Mukhadushika is described under Kshudra rogas in Sushrut Samhita[4], Madhav nidan[5], Ashtang sangraha[6], Ashtang Hriday[7] and Sharangdhar samhita[8]. There are no as  such  specific etiological factors are described in  texts regarding mukhadushika.

 As Perfect skin is, for most people, a distant dream. Chronic skin conditions typically are not curable in western system of medicine, but they can be manageable using Ayurvedic therapies and by paying close attention to our lifestyle. This case is a example of Mukhadushika like skin disease can be managed with Ayurvedic therapy. The combination of drugs selected ( Manjishtha,Patol,Sariva, Musta, Kutaki, Amalragandhi haridra, Patha )[9] will act over the pathological aspect of the disease breaking pathology as whole with maintaining the asthestic value.



Need of study

It is a celebrity topic in dermatology and it is not only  harming physically but mentally and socially too….   Hence it is matter of concern!!!

 We all have seen college going students literally going into depression , trying out all the possible ways to treat acne. Hence some or the other way they land up in buying costlier medicines. Majority of  acne case if left untreated it may turn into scar formation or hyperpigmentation (PIH). only Local applications ,creams  gives temporary relief but may lead to recurrence. Ayurvedic formulations given internally can act over the targeted dosha ( vata, kapha and Rakta) in order to break the pathology and treating disease as whole.

 


Group of patients:

 

Group I:         No. of Patients: 44

Treatment: Jatiphaladi Lepa once a day over the acne.

 

Group II  :      No. of Patients: 44

Treatment:  Jatiphaladi Lepa over the acne and Khadirashtak kwatha (20ml) orally twice a day.

Investigations 

Blood CBC ,ESR,Lipid Profile, BSL Fasting and Post prandial 


SUMMARY & CONCLUSION

The work will be summarized to make final conclusions. Observation of result will be concluded with statistical analysis under the heading conclusion with explanation at the end of whole research. The data collected from CRF will be subjected to statistical analysis, appropriate statistical tests will be applied to the data generated and significance of improvements will be studied.


 
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