| CTRI Number |
CTRI/2024/09/073631 [Registered on: 09/09/2024] Trial Registered Prospectively |
| Last Modified On: |
27/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Role of herbal formulation in the management of melasma |
|
Scientific Title of Study
|
Clinical study to evaluate the efficacy of varnya yoga (manjishtha-yashtimadhu-sariva)in the management of vyanga(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 Subir Kumar Khan |
| Designation |
reader , Department of kayachikitsa |
| Affiliation |
The West Bengal University of Health Sciences, Kolkata |
| Address |
Institute of Post Graduate Ayurvedic Education And Reasearch at SVSP hospital .
OPd no 1
Department Of Kayachikitsa
294/3/1, Α.Ρ.C Road, Kolkata-700009
DD 36, 2nd Avenue, DD Block, Sector 1, Bidhannagar, Kolkata, West Bengal 700064
Kolkata
WEST BENGAL
700009
India |
| Phone |
8944006115 |
| Fax |
|
| Email |
subirkrkhan2018@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Subir Kumar Khan |
| Designation |
reader , Department of kayachikitsa |
| Affiliation |
The West Bengal University of Health Sciences, Kolkata |
| Address |
Institute of Post Graduate Ayurvedic Education And Reasearch at SVSP hospital .
OPd no 1
Department Of Kayachikitsa
294/3/1, Α.Ρ.C Road, Kolkata-700009
DD 36, 2nd Avenue, DD Block, Sector 1, Bidhannagar, Kolkata, West Bengal 700064
Kolkata
WEST BENGAL
700009
India |
| Phone |
8944006115 |
| Fax |
|
| Email |
subirkrkhan2018@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rijuana sultana |
| Designation |
PG Scholar Department of Kayachikitsa |
| Affiliation |
The West Bengal University of Health Sciences, Kolkata |
| Address |
Institute of Post Graduate Ayurvedic Education And Reasearch at SVSP hospital .
OPd no 1
Department Of Kayachikitsa
294/3/1, Α.Ρ.C Road, Kolkata-700009
Kolkata
WEST BENGAL
700009
India |
| Phone |
9064344520 |
| Fax |
|
| Email |
rijuanasultana1995@gmail.com |
|
|
Source of Monetary or Material Support
|
| Govrenment Of Health and family welfare Swasthya Bhawan GN-29 Sector-V, Salt Lake, Street Number 2, Kolkata, West Bengal 700091 |
|
|
Primary Sponsor
|
| Name |
Institute of Post Graduate Ayurvedic Education And Reasearch at SVSP hospital |
| Address |
Institute of Post Graduate Ayurvedic Education And Reasearch at SVSP hospital .
OPd no 1
Department Of Kayachikitsa
294/3/1, Α.Ρ.C Road, Kolkata-700009 |
| 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 Rijuana Sultana |
Institute of Post Graduate Ayurvedic Education And Reasearch at SVSP hospital . |
Institute of Post Graduate Ayurvedic Education And Reasearch at SVSP hospital .
OPd no 1
Department Of Kayachikitsa
294/3/1, Α.Ρ.C Road, Kolkata-700009
Kolkata
WEST BENGAL |
9064344520
rijuanasultana1995@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L814||Other melanin hyperpigmentation. Ayurveda Condition: VYANGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: MANJISHTHA YASHTIMADHU SARIVA, Reference: CHARAK SAMHITA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: WATER), Additional Information: (2) Medicine Name: , Reference: MANJISHTHA YASHTIMADHU SARIVA, Route: CHARAK SAMHITA, Dosage Form: Churna/ Powder, Dose: 39(0), Frequency: NA, Bhaishajya Kal: bd, Duration: Abhakta, anupAna/sahapAna: No, Additional Information: -(3) Medicine Name: , Reference: MANJISHTHA YASHTIMADHU SARIVA, Route: CHARAK SAMHITA, Dosage Form: Churna/ Powder, Dose: 9(5), Frequency: g, Bhaishajya Kal: bd, Duration: Adhobhakta, anupAna/sahapAna: No, Additional Information: WATER | | 2 | Comparator Arm | Procedure | - | lepa, लेप | (Procedure Reference: susruta samhita sutra sthan chap 18/ 04, Procedure details: lepa should be done in protiloma way (in the upward direction) by this way medicine ( manjishtha , yashtimadhu,sariva powder ) stay on the affected face properly for 20 minutes ,twice in a day morning and evening with water . thickness of lepa should be equal to that of the 0.25 cm )
(1) Medicine Name: manjistha yastimadhu sariva , Reference: charak samhita 04/, Route: Topical, Dosage Form: Churna/ Powder, Dose: 10(g), Frequency: bd, Duration: 45 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Clinical features like
From ayurvedic text Neeruja(painless)Tanu(thin)
Shyava Varna Yuktamandala (blue patches) on Mukhapradesh
Hyperpigmented macules on face as per modern text.
Patient are not under other medicine for melasma.
patients willing for trial |
|
| ExclusionCriteria |
| Details |
Blackish and Reddish brown spot present all over the body exists since birth
Any hyperpigmented patches due to leprosy will be excluded
Hyper pigment caused by tumour like malignant melanoma.
Hyperpigmented spot due to some endocrine and metabolic disorder like Addisons disease, Nelsons disease, Haemochromatosis, Pellagra
Acne vulgaris,Inflammatory pigmentation Pregnant women, Lactating mother |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| oral use of varnya yoga may show better result in the symptoms like kandu, rukshata, daha, hyperpigmentation and reduction in size and number of patches |
45 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| external use of varnya yoga may show better result in the symptoms like kandu, rukshata, daha, hyperpigmentation & reduction in size & number of patches |
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 3 |
|
Date of First Enrollment (India)
|
12/09/2024 |
| 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="3"
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
|
Vyanga, described in classical Ayurveda text under Kshudra Roga, is a hyperpigmentation disorder characterized by painless (Niruja) thin (Tanu) and brownish black (Shyava mandala) patches on the face. Vyanga is primarily caused by vitiation of Pitta Dosha and Vata Dosha. This disease may be co related with melasma due to similar clinical features. Despite its ancient origin, Vyanga (melasma) remains a significant cosmetic concern, especially among women. It’s chronic and refractory nature calls for deeper understanding of its causes and effective treatments21. Ayurveda offers a holistic management approach through herbal remedies, dietary changes and lifestyle modification focusing on restoring Doshic balance and overall health. There are so many preparations mentioned in our ayurvedic classics to treat Kshudra Roga.It is expected that the present work Manjishtha (Rubia cordifolia Linn), Yashtimadhu (Glycyrrhiza glabra Linn) and Sariva (Hemedismus indicus R.Br.) will be effective solution on this,distressful aliments as lepa as well as oral use. |