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CTRI Number  CTRI/2025/06/088782 [Registered on: 13/06/2025] Trial Registered Prospectively
Last Modified On: 31/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Process of Care Changes 
Study Design  Single Arm Study 
Public Title of Study   A study to evaluate the effect of Dushivishari Agad tablets orally and Arjuntwak Churna for facepack in the treatment of Melasma. 
Scientific Title of Study   A single-arm clinical study to evaluate the efficacy of Dushivishari Agad orally and Arjuntwak churna lepa in the management of Vyanga with special reference to Melasma 
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 Shivali Ajay Nimgale  
Designation  MD (Agadtantra Evum Vidhi Vaidyak) schlor 
Affiliation  MAMs Sumatibhai Shah Ayurveda Mahavidyalaya Malwadi Hadapsar Pune 
Address  0PD no.4, Agadtantra department ,ground floor, Sane Guruji Arogya Kendra , Malwadi, Hadapsar ,Pune ,411028

Pune
MAHARASHTRA
411028
India 
Phone  8177898891  
Fax    
Email  shivalinimagle1203@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vidya Undale Newaskar 
Designation  Associate professor  
Affiliation  MAMs Sumatibhai Shah Ayurveda Mahavidyalaya Malwadi Hadapsar Pune 
Address  0PD no.4, Agadtantra department ,ground floor, Sane Guruji Arogya Kendra , Malwadi, Hadapsar ,Pune ,411028

Pune
MAHARASHTRA
411028
India 
Phone  9422345801  
Fax    
Email  undale.vidya@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Vidya Undale Newaskar 
Designation  Associate professor  
Affiliation  MAMs Sumatibhai Shah Ayurveda Mahavidyalaya Malwadi Hadapsar Pune 
Address  0PD no.4, Agadtantra department ,ground floor, Sane Guruji Arogya Kendra , Malwadi, Hadapsar ,Pune ,411028
0PD no.4, Agadtantra department ,ground floor, Sane Guruji Arogya Kendra , Malwadi, Hadapsar ,Pune ,411028
Pune
MAHARASHTRA
411028
India 
Phone  9422345801  
Fax    
Email  undale.vidya@gmail.com  
 
Source of Monetary or Material Support  
MAMs Sumatibhai Shah Ayurveda College OPD no. 4 Agadtantra Department Ground Floor Sane Guruji Arogya Kendra Hadapsar Pune -411028 Maharashtra India 
 
Primary Sponsor  
Name  Dr . Shivali Ajay Nimgale 
Address  OPD no. 4 Agadtantra Department Ground Floor Sane Guruji Arogya Kendra Hadapsar Pune -411028 Maharashtra India  
Type of Sponsor  Other [self] 
 
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 
DrShivali Nimgale  Sane Guruji Arogya Kendra Malwadi Hadapsar Pune 411028  OPD NO 4 Agadtantra Department Ground floor Sane Guruji Arogya Kendra Malwadi Hadapsar Pune 411028
Pune
MAHARASHTRA 
8177898891

shivalinimagle1203@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee MAMS Sumatibhai Shah Ayurved Mahavidyalaya and Sane Guruji Arogya Kendra  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L811||Chloasma. Ayurveda Condition: VYANGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Arjuntwak Churna, Reference: Sharangdhar Samhita, Route: Topical, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 2 Months, anupAna/sahapAna: No, Additional Information: -
2Intervention ArmDrugClassical(1) Medicine Name: Dushivishari Agad, Reference: sushruta Kalpasthan, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: -water), Additional Information: -
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  pts comimg to Sane Guruji Arogya Kendra having Sign and Symptoms of Vyanga (Melasma) will be selected irrespective of their gender , community, caste and economic status 
 
ExclusionCriteria 
Details  1. Patient with present and past history of any skin diseases like psoriais, eczema.
2. Pregnant and lactating women .
3. Patients having Hyperpigmentation due to Addisons Diseases, cushings Diseases.
Already Diagnosed Thyroid Diseases. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
MASI SCALE
GRADE SCALE
To evaluate the efficacy of Dushivishari Agad orally and Arjun Twak churna lep in the management of Vyanga with special reference to melasma 
baseline 15th day 30th day 45th day and 60th day 
 
Secondary Outcome  
Outcome  TimePoints 
To observe adverse effect of Dushivishari Agad and Arjunchurna lepa   baseline 15th day 30th day 45th day 60th day 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   20/06/2025 
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="0"
Months="1"
Days="6" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  
Melasma is a hyperpigmentation disorder of skin. It causes hyperpigmented causes on cheeks, chin  upper lips, nose and forehead. Skin is the biggest organ of the body.  Now a days harmful toxins like UV radiation, environmental pollution, use of cosmetics, oral contraceptive pills etc have direct effect on skin  which leads to skin disorders . This toxins get accumulated in the body and causes skin diseases like melasma . It is also called as Chloasma. In contemporary medicine, melasma is treated with use of steroids, skin peeling, chemical peeling, PRP like procedures, which may have many side effects which are yet to be known and are quite expensive for economically poor people.  Ayurveda  treatment is safe, convenient, cheap and easy to use. This study includes use of Dushivishari Agad orally and arjuntwak churna for external application . This are herbal formulations which  includes herbs having  specific properties like anti itching, blood purifying, anti poisonous, skin brightening etc.

Contents of Dushivishari Agad 
Piper nigrum ( pippali)
Cybopogon martini (Dhyamak)
Nordostachy jatamansy ( jatamansi)
Symplococus racemosa ( Shaavara)
 Cyperus rotundus (Musta )
Tribulus terristris ( Suvarchika)
Pavonia odorata (Toya )
Elitaria cardamomum ( Sukshma ela)
Red ochre ( kanak gairik)

And Arjuntwak churna is the powdered form of skin of Arjun plant bark.
Dushivishari Agad will me given in tablet forms in dose of 500 mg BD and Arjun twak churna will be used as face pack for external application on the affected area for 2 months. 4 Follow ups after every 15 days will be carried out on 15th, 30th, 45th and 60th day. Grade scale which induces grading of skin color, itching, dryness, oiliness, diameter, burning sensation  along with MASI SCALE (Melasma Area and Severity Index)  will be used as a assessment parameter. Before treatment  and After treatment  will me compared and discussion will be made on observations. Conclusion will be drawn on the basis of discussion.
 
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