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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition:L811||Chloasma. Ayurveda Condition: VYANGAH, |
|
Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Intervention Arm | Drug | Classical | | (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: - | 2 | Intervention Arm | Drug | Classical | | (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. |