| CTRI Number |
CTRI/2024/11/076870 [Registered on: 18/11/2024] Trial Registered Prospectively |
| Last Modified On: |
08/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
AYURVEDIC TREATMENT FOR MELASMA USING AYURVEDIC MEDICINES.THE TREATMENT CONSISTS OF TAKING INTERNAL AND EXTERNAL MEDICATIONS. |
|
Scientific Title of Study
|
CLINICAL EVALUATION OF THE CONCEPT OF LEPA AND KASHAYAPAN IN THE MANAGEMENT OF VYANGH |
| Trial Acronym |
INTERVENTIONAL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR KAJAL JAIN |
| Designation |
MD SCHOLAR PG DEPARTMENT OF SAMHITA SIDDHANTA DEPARTMENT |
| Affiliation |
Pt. KHUSHILAL SHARMA GOVT. AUTONOMOUS AYURVEDA MEDICAL COLLEGE AND INSTITUTE |
| Address |
ROOM NO 231, PG DEPARTMENT OF SAMHITA SIDDHANTA, PT KHUSHILAL SHARMA GOVERMENT AUTONOMOUS AYURVEDIC MEDICAL COLLEGE AND INSTITUTE BHOPAL
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
8966828488 |
| Fax |
|
| Email |
jain1995.kajal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr LAJWANTI KESWANI |
| Designation |
READER AND HOD OF DEPARTMENT OF SAMHITA SIDDHANTA |
| Affiliation |
Pt. khushilal sharma govt. auto. ayurveda college and institute |
| Address |
ROOM NO. 231 PG DEPARTMENT OF SAMHITA SIDDHANTA, PANDIT KHUSHILAL SHARMA GOVERNMENT AUTONOMOUS AYURVEDIC MEDICAL COLLEGE AND INSTITUTE
ROOM NO. 231 PG DEPARTMENT OF SAMHITA SIDDHANTA, PANDIT KHUSHILAL SHARMA GOVERNMENT AUTONOMOUS AYURVEDIC MEDICAL COLLEGE AND INSTITUTE
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
9131882793 |
| Fax |
|
| Email |
123laj321@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr KAJAL JAIN |
| Designation |
MD SCHOLAR PG DEPARTMENT OF SAMHITA SIDDHANTA |
| Affiliation |
Pt. khushilal sharma government autonomous ayurvedic medical college and institute |
| Address |
ROOM NO. 231 PG DEPARTMENT OF SAMHITA SIDDHANTA, PANDIT KHUSHILAL SHARMA GOVERNMENT AUTONOMOUS AYURVEDIC MEDICAL COLLEGE AND INSTITUTE
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
8966828488 |
| Fax |
|
| Email |
jain1995.kajal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pandit khushilal sharma government autonomous ayurvedic medical c college and institute Bhopal mp |
|
|
Primary Sponsor
|
| Name |
PANDIT KHUSHILAL SHARMA GOVERNMENT AUTONOMOUS AYURVEDIC MEDICAL COLLEGE AND INSTITUTE |
| Address |
SCIENCE HILLS BEHIND MANIT, KOLAR BYPASS NEHRU NAGAR BHOPAL, PANDIT KHUSHILAL SHARMA GOVERNMENT AUTONOMOUS AYURVEDIC MEDICAL COLLEGE AND INSTITUTE BHOPAL |
| Type of Sponsor |
Research institution and hospital |
|
|
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 KAJAL JAIN |
Pandit khushilal sharma government autonomous ayurvedic medical college and institute |
Pandit Khushilal sharma government autonomous ayurvedic medical College and institute Science hills behind Manit kolar bypass nehru nagar bhopal Department of Samhita Siddhanta,room no 231
Bhopal
MADHYA PRADESH |
8966828488
jain1995.kajal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMITTEE PT. KHUSHILAL SHARMA GOVERNMENT AUTONOMOUS AYURVEDIC MEDICAL COLLEGE AND INSTITUTE BHOPAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L80-L99||Other disorders of the skin and subcutaneous tissue. Ayurveda Condition: VYANGAH, (2) ICD-10 Condition:L814||Other melanin hyperpigmentation. Ayurveda Condition: VYANG, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: patoladi kashaya , Reference: astanghridaya sutra 15/15 , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -lukewarm water), Additional Information: n/a | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: VYANGHNASHAK LEPA, Reference: BHAVPRAKSH MADHYAM KHAND 61/39, Route: Topical, Dosage Form: Taila, Dose: 5(drops), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: -Vyanghnashak lepa is converted in the form of serum |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1.Participants aged between 20 to 55 years.
2.Participants fulfilling the criteria of diagnosis of Vyang (melasma).
3.Participants willing to provide informed written consent prior to initiation of study. |
|
| ExclusionCriteria |
| Details |
Participants having age less than 20yrs and more than 55yrs.
2. Participants suffering with other systemic disorders like renal failure, hepatic disorders, cancer, HIV and endocrine system related disorders with prolonged medication history.
3.Accidental cases like burn, fracture & animal or insects bite is also excluded.
4.Disease like Freckles, solar lentigo, Toxic melanoderma, RiehlÂ’s melanosis, Drug induced photosensitivity, Frictional melanosis, Lichen planus pigmentosa, Ochronosis, Cutaneous erythematous lupus, are to be excluded.
5.Pregnant and lactating women
6.Exanthematous rashes or any other inflammatory skin disease.
7.Congenital anomalies. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in subjective and objective criterias assessed |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| prolonged effect of ayurvedic interventions in the management of vyangh (Melasma) |
45 Days |
|
|
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 1 |
|
Date of First Enrollment (India)
|
15/01/2025 |
| 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="6"
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
|
For the cliical study of vyang patients fulfilling the criteria of diagnosis and criteria for inclusion of present study from opd of pt khushilal sharma govt ayurveda medical college and hospital bhopal mp.
STUDY DESIGN- The study will be designed as a Randomised controlled clinical trial and sample will be selected by simple random technique.
SAMPLE SIZE- Study will be conducted on 60 patients divided into 3 groups of 20 patients each.
STUDY DURATION- 45 days
FOLLOW UP- in every 15 days for duration of treatment (assesssment days -3 once in 15 days) |