| CTRI Number |
CTRI/2025/10/096162 [Registered on: 16/10/2025] Trial Registered Prospectively |
| Last Modified On: |
16/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical study to see the result of Arjuna,Manjistha and Vasa patra churna lepa with Madhu Facial Hyperpigmentation |
|
Scientific Title of Study
|
A Pharmaco-clinical study to evaluate the effectiveness of Arjuna[Terminalia arjuna Roxb],Manjistha[Rubia cardifolia Linn] and Vasa[Adhatoda vasica Nees] patra churna lepa with Madhu in the management of Vyanga w.s.r. 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 |
Sweta Gupta |
| Designation |
MD Scholar |
| Affiliation |
State Ayurvedic College and Hospital Lucknow |
| Address |
P.G Dept.of dravyaguna State Ayurvedic College and Hospital Lucknow 226003
Uttar Pradesh
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
7897489902 |
| Fax |
|
| Email |
gupta.sweta2020@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ramanand |
| Designation |
Lecturer Dravyaguna Department State Ayurvedic College and Hospital, Lucknow |
| Affiliation |
State Ayurvedic College and Hospital Lucknow |
| Address |
P.G Dept. of dravyaguna State Ayurvedic College and Hospital, Lucknow 226003 Uttar Pradesh
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9045699482 |
| Fax |
|
| Email |
dr.ramanand72@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ramanand |
| Designation |
Lecturer Dravyaguna Department State Ayurvedic College and Hospital, Lucknow |
| Affiliation |
State Ayurvedic College and Hospital Lucknow |
| Address |
P.G Dept. of dravyaguna State Ayurvedic College and Hospital, Lucknow 226003 Uttar Pradesh
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9045699482 |
| Fax |
|
| Email |
dr.ramanand72@gmail.com |
|
|
Source of Monetary or Material Support
|
| State Ayurvedic College and Hospital,Lucknow |
|
|
Primary Sponsor
|
| Name |
State Ayurvedic College and Hospital,Lucknow |
| Address |
State Ayurvedic College and Hospital,Lucknow, 226003, Uttar Pradesh , India |
| Type of Sponsor |
Government 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 |
| DrSweta Gupta |
State Ayurvedic College and Hospital,Lucknow |
State Ayurvedic College and Hospital,Lucknow 226003, Uttar Pradesh , India
Lucknow
UTTAR PRADESH |
7897489902
gupta.sweta2020@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of Institutional ethics Committee State Ayurvedic College and Hospital Lucknow Tulsidas marg,turiyaganj pincode -226003 Uttar Pradesh 226003 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L814||Other melanin hyperpigmentation. Ayurveda Condition: VYANG, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Arjuna,Manjistha,vasa powder, Reference: Yogratnakar Kshudra Rog chikitsa Adhyaya Vyanga chikitsa Shlok no 8, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: lukewarm water), Additional Information: arjuna, manjistha ,vasa churna mixed with honey will be applied locally to the affected area | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Arjuna,Manjistha,Vasa powder with Honey, Reference: Yogratnakar Kshudrarog chikitsa Adhyaya Vyanga chikitsa Shlok no 8, Route: Topical, Dosage Form: Lepa Churna, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Both acute and chronic cases of vyanga with special reference to mealasma will be treated .patient willing to participate in above mentioned trial .Diagnosed with classical features of vyanga as described in samhitas. |
|
| ExclusionCriteria |
| Details |
Age group less than 30 years and more than 50 years
Hyper pigmentation caused due to any known cases of systemic diseases like Addison disease,Cushing syndrome.
People suffering from chronic liver and renal disorders.
Hyper pigmentation caused by tumors like malignant
melanoma
Pregnant women
patients who are on chemotherapy or radiotherapy will be excluded. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Essential criteria
1 Shyavavarna[grey brown]
2 Niruja[painless]
3 Tanu[non elevated]
4 Mandal[patches with irregular border]
Non Essential criteria
1 Familial history
2 Sun exposure
Objective criteria
1 Area of lesion
2 Visibility of pigmentation |
Tthe follow up conducted during study period for once in 15 days.After completion of trial of two months ,the follow up without drug after 15th day
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
CBC
LFT,KFT
Bloodsugar[random/fasting/pp/HbA1c]
Lipid profile
Thyroid profile
|
the follow up conducted during study period for once in 15 days
After completion of trial of two months ,the follow up without drug after 15th day |
|
|
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 2 |
|
Date of First Enrollment (India)
|
04/11/2025 |
| 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="0"
Months="8"
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
|
Women of middle age often suffers with dark patches on face generally on cheeks forehead and nose, which often decreases their confidence and make them stressful for their appearance ,therefore i have selected this trial.This research evaluate the efficacy of arjun,manjistha and vasa powder .This research is parallel group randomised clinical study of 60 patients. Group A [[n =30] - Arjun ,manjistha and vasa powder lepa with honey will be given for external application twice a day for a period of two months Group B [n = 30] - This group is proposed to be given lepa twice along with it the powder will be also given for internal use twice daily with lukewarm water after meal for a period of two month. Duration of trial - 2 months Follow up = the follow up conducted during study period for once in 15 days,after completion of trial of two months,the follow up without drug after 15 days for one month. |