| CTRI Number |
CTRI/2025/02/080895 [Registered on: 19/02/2025] Trial Registered Prospectively |
| Last Modified On: |
18/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical investigation to study the effect of Yavadi lepa externally with Sarivadyasava orally in comparison with Yashtimadhuchurna lepa externally with Sarivadyasava orally in Melasma in Adults of age group 30-60years for a period of 30 days. |
|
Scientific Title of Study
|
To study the efficacy of Yavadi lepa with Sarivadyasava in comparison with Yashtimadhuchurna lepa with Sarivadyasava in Vyanga-A controlled randomized clinical study |
| 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 Amrutha C S |
| Designation |
Post Graduate Scholar |
| Affiliation |
Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Bengaluru |
| Address |
Dept of Kayachikitsa OPD Number.1,2,3,18,27, Shri Dharmasthala
Manjunatheshwara Institute of Ayurveda and Hospital, SH 17
Anchepalya, Kumbalagodu post, Bengaluru- 560074, Karnataka,
India
Bangalore
KARNATAKA
560074
India |
| Phone |
9108347001 |
| Fax |
|
| Email |
dramrutha@sdmayurbangalore.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priya Bhat |
| Designation |
Associate professor |
| Affiliation |
Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Bengaluru |
| Address |
Dept of Kayachikitsa OPD Number.3, Shri Dharmasthala
Manjunatheshwara Institute of Ayurveda and Hospital, SH 17
Anchepalya, Kumbalagodu post, Bengaluru- 560074, Karnataka,
India
Bangalore
KARNATAKA
560074
India |
| Phone |
9986451162 |
| Fax |
|
| Email |
dr.priyabhat23@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amrutha C S |
| Designation |
Post Graduate Scholar |
| Affiliation |
Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Bengaluru |
| Address |
Dept of Kayachikitsa OPD Number.1,2,3,18,27, Shri Dharmasthala
Manjunatheshwara Institute of Ayurveda and Hospital, SH 17
Anchepalya, Kumbalagodu post, Bengaluru- 560074, Karnataka,
India
Bangalore
KARNATAKA
560074
India |
| Phone |
9108347001 |
| Fax |
|
| Email |
dramrutha@sdmayurbangalore.in |
|
|
Source of Monetary or Material Support
|
| Dept of Kayachikitsa OPD No.1,2,3,18,27 Shri Dharmasthala
Manjunatheshwara Institute of Ayurveda and Hospital, SH 17
Anchepalya, Kumbalagodu post, Bengaluru- 560074, Karnataka,
India |
|
|
Primary Sponsor
|
| Name |
Dr Amrutha C S |
| Address |
Dept of Kayachikitsa OPD Number.1,2,3,18,27 Shri Dharmasthala
Manjunatheshwara Institute of Ayurveda and Hospital, SH 17
Anchepalya, Kumbalagodu post, Bengaluru- 560074, Karnataka,
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 |
| Dr Amrutha C S |
Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Bengaluru |
Dept of Kayachikitsa OPD No.1,2,3,18,27 Shri Dharmasthala
Manjunatheshwara Institute of Ayurveda and Hospital, SH 17
Anchepalya, Kumbalagodu post, Bengaluru- 560074, Karnataka,
India
Bangalore
KARNATAKA |
9108347001
dramrutha@sdmayurbangalore.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Shri Dharmasthala Manjunatheshwara Ayurveda and Hospital |
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: Yavadi lepa, Reference: BHAISHAJYA RATNAVALI KSHUDRA ROGA CHIKITSADHYAYA 65th CHAPTER 37 SHLOKA (65/37), Route: Topical, Dosage Form: Lepa Churna, Dose: 5(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Sarivadyasava, Reference: BHAISHAJYA RATNAVALI PRAMEHA PIDAKA ADHIKARA 52nd CHAPTER 22 to 27 SHLOKA (52/22-27), Route: Oral, Dosage Form: Asava, Dose: 15(ml), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Ushna jala), Additional Information: - | | 3 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Yashtimadhuchurna lepa, Reference: BHAVAPRAKASHA HARITAKYADI VARGA 145 to 146 SHLOKA , Route: Topical, Dosage Form: Lepa Churna, Dose: 5(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - | | 4 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Sarivadyasava , Reference: BHAISHAJYA RATNAVALI PRAMEHA PIDAKA ADHIKARA 52nd CHAPTER 22 to 27 SHLOKA (52/22-27), Route: Oral, Dosage Form: Asava, Dose: 15(ml), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Ushna jala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects with classical lakshana of Vyanga - Niruja, tanu, shyavavarna mandala.
2.Subjects with either sex irrespective of religion within the age group of 30 to 60 years
|
|
| ExclusionCriteria |
| Details |
1.Subjects suffering from other systemic disorders like Addison’s disease, Cushing’s syndrome, Lichen planus pigmentosa, Chronic renal failure, Drug induced photosensitivity, Uncontrolled Diabetes.
2.Subjects who are pregnant, lactating women.
3.Subjects who are on oral contraceptive pills.
4.Subjects with age less than 30 years and more than 60 years.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in reduction of signs and symptoms in patients diagnosed with Vyanga with MASI Score |
0th day(Baseline), 15th day, 30th day and 45th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in reduction of signs and symptoms in patients diagnosed with Vyanga based on Melasma severity score. |
0th day(Baseline), 15th day, 30th day and 45th 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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/03/2025 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
A controlled clinical study on the efficacy of Yavadi lepa externally with Sarivadyasava orally in the management of Vyanga (Melasma) in adults of age group 30-60 years for a period of 30 days. During this study period 30 subjects diagnosed with Vyanga (Melasma) will be recruited and divided into two groups, Group A (Trial drug/Intervention group) and Group B (Control drug/Comparator group) 15 subjects in each group respectively. Group A (Trial drug/Intervention group) it includes 15 subjects qualifying inclusion criteria of the current study will be given Yavadi lepa externally in the dose of 5gm mixed with jala with Sarivadyasava orally in the dose of 15ml after food for 30days starting from day-01 of trial, assessment of the patient during trial on 0th day(baseline), 15th day, 30th day and after trial follow up on 45th day. Group B (Control Drug/Comparator Group) it includes 15 subjects qualifying inclusion criteria of the current study will be given Yashtimadhuchurna lepa externally in the dose of 5gm mixed with jala with Sarivadyasava orally in the dose of 15ml after food for 30days starting from day-01 of trial, assessment of the patient during trial on 0th day(baseline),15th day, 30th day and after trial follow up on 45th day. The primary outcome measure will be significant improvement noticed in Melasma area and severity index score (MASI) of Melasma after 30 days. The secondary outcome measure will be improvement noticed in reduction of signs and symptoms of Vyanga based on Melasma severity score after 30 days. Statistical analysis will be done through data obtained based on, before and after treatment assessment. |