| CTRI Number |
CTRI/2025/04/085353 [Registered on: 23/04/2025] Trial Registered Prospectively |
| Last Modified On: |
15/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
Effect of Arjun Manjistha combined and Ingudi in treatment of Melasma |
|
Scientific Title of Study
|
A clinico comparative study of Arjuna Twak (Terminalia arjuna Linn) with Manjistha (Rubia cordifolia Linn) Pralepa and Ingudi (Balanites aegyptiaca Del) Pralepa in the management of Vyanga WSR 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 Neha Yadav |
| Designation |
PG Scholar |
| Affiliation |
Govt Auto Dhanwantri Ayurved Medical College |
| Address |
Department of Dravyaguna, Govt Auto Dhanwantri Ayurved Medical College Mangalnath Road Ujjain
Ujjain
MADHYA PRADESH
456001
India |
| Phone |
7974947234 |
| Fax |
|
| Email |
yneha9810@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunita D Ram |
| Designation |
Reader |
| Affiliation |
Govt Auto Dhanwantri Ayurved Medical College |
| Address |
Govt Auto Dhanwantri Ayurved Medical College Mangalnath Road Ujjain MP India
Ujjain
MADHYA PRADESH
456001
India |
| Phone |
9424014827 |
| Fax |
|
| Email |
drsunitadram72@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sunita D Ram |
| Designation |
Reader |
| Affiliation |
Govt Auto Dhanwantri Ayurved Medical College |
| Address |
Department of Dravyaguna Govt Auto Dhanwantri Ayurved Medical College Mangalnath Road Ujjain MP India
MADHYA PRADESH
456001
India |
| Phone |
9424014827 |
| Fax |
|
| Email |
drsunitadram72@gmail.com |
|
|
Source of Monetary or Material Support
|
| Govt Auto Dhanwantri Ayurved Medical College Ujjain MP India 456001 |
|
|
Primary Sponsor
|
| Name |
Govt Auto Dhanwantri Ayurved Medical College |
| Address |
Govt Auto Dhanwantri Ayurved Medical College Mangalnath Road Ujjain MP India 456001 |
| 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 |
| Dr Neha Yadav |
Govt Auto Dhanwantri Ayurved Medical College |
Dept of Dravyaguna Govt Auto Dhanwantri Ayurved Medical College Mangalnath Road Ujjain MP India 456001
Ujjain
MADHYA PRADESH |
7974947234
yneha9810@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L818||Other specified disorders of pigmentation. Ayurveda Condition: VYANGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Ingudi , Reference: Rajamartand Mukhroga Adhikar 19, Route: Topical, Dosage Form: Lepa Churna, Dose: 5(g), Frequency: od, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 45 Days, Reference: No, Route: NA, Dosage Form: Lepa Churna, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Arjuna, Reference: Chakradutta Chikitsa 55/44, Route: Topical, Dosage Form: Lepa Churna, Dose: 3(g), Frequency: od, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 45 Days, Reference: No, Route: NA, Dosage Form: Lepa Churna, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (3) Medicine Name: Manjistha , Reference: Astang Sangrah Uttar 37/19, Route: Topical, Dosage Form: Lepa Churna, Dose: 3(g), Frequency: od, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (4) Medicine Name: 45 Days, Reference: No, Route: NA, Dosage Form: Lepa Churna, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients presenting classical signs and symptoms of Vyanga
Patient willing to sign consent form
Patient fit for taking this medicine |
|
| ExclusionCriteria |
| Details |
Melasma due to tuberculosis therapy and malignant cases allergy carcinoma burns herpes eczema psoriasis measles leprosy uncontrolled hormonal disease
patients who are reporting allergic history of trial drug |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| change in sign and symptoms of disease |
change in sign and symptoms of disease at 7th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| assessment of changes in clinical parameter after 15 days |
1st follow up at 15th day
2nd follow up at 30th day
after treatment 45th 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/ Phase 3 |
|
Date of First Enrollment (India)
|
30/04/2025 |
| 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 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
|
This is randomized interventional " A Clinico Comparative study of Arjuna Twak (Terminalia arjuna Linn.) with Manjistha (Rubia cordifolia Linn.) Pralepa and Ingudi (Balanites aegyptiaca Del.) Pralepa in the management of Vyanga W.S.R to Melasma". Patients will be selected randomly for the study and will be divided into 2 groups. Each group will contain 30 patients. For the present study patients of either sex having the age group of 18 to 60 years who will present with complains of sign and symptoms of Vyanga w.s.r. to Melasma will be selected irrespective of their religion and occupation etc. from the OPD of Government Dhanwantri Ayurveda medical College & Hospital Ujjain M.P. |