| CTRI Number |
CTRI/2021/01/030511 [Registered on: 15/01/2021] Trial Registered Prospectively |
| Last Modified On: |
15/01/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Ayurvedic management Of Alopecia |
|
Scientific Title of Study
|
A Comparative study to evaluate the added effect of Gokshuradi Lepa and Dhaturapatra Lepa after Prachanna in Indralupta |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Soundarya N |
| Designation |
PG Scholar |
| Affiliation |
Rajiv Gandhi University Of Health Sciences, Bengaluru |
| Address |
Department of PG studies in Shalakya Tantra OPD,Room No-11.Government Ayurveda Medical College ,Dhanwantari Road Bengaluru
Department of PG studies in Shalakya Tantra OPD,Room No-11.Government Ayurveda Medical College ,Dhanwantari Road Bengaluru
Bangalore KARNATAKA 560009 India |
| Phone |
9686681323 |
| Fax |
|
| Email |
soundaryareddy13@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Rathi S |
| Designation |
Associate Professor |
| Affiliation |
Rajiv Gandhi University Of Health Sciences, Bengaluru |
| Address |
Department of PG studies in Shalakya Tantra OPD,Room No-11.Government Ayurveda Medical College ,Dhanwantari Road Bengaluru Department of PG studies in Shalakya Tantra OPD,Room No-11.Government Ayurveda Medical College ,Dhanwantari Road Bengaluru Bangalore KARNATAKA 560009 India |
| Phone |
8970779550 |
| Fax |
|
| Email |
drrathi.s@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Soundarya N |
| Designation |
PG Scholar |
| Affiliation |
Rajiv Gandhi University Of Health Sciences Bengaluru |
| Address |
Department of PG studies in Shalakya Tantra OPD,Room No-11.Government Ayurveda Medical College ,Dhanwantari Road Bengaluru Department of PG studies in Shalakya Tantra OPD,Room No-11.Government Ayurveda Medical College ,Dhanwantari Road Bengaluru Bangalore KARNATAKA 560009 India |
| Phone |
9686681323 |
| Fax |
|
| Email |
soundaryareddy13@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.Soundarya.N |
| Sri Jayachamarajendra Institute of Indian Medicine Hospital, Government Ayurveda Medical College Campus, Bengaluru-560009 |
|
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Primary Sponsor
|
| Name |
Dr Soundarya N |
| Address |
Department of PG studies in Shalakya Tantra OPD,Room No-11.Government Ayurveda Medical College ,Dhanwantari Road Bengaluru |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Soundarya N |
Sri Jayachamarajendra Institute Of Indian Medicine Hospital |
Shalakya tantra OPD Room No-11, Government Ayurveda Medical College Campus, Dhanwantari Road Bengaluru Bangalore KARNATAKA |
9686681323
soundaryareddy13@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Government Ayurveda Medical College,Bengaluru |
Approved |
|
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L639||Alopecia areata, unspecified. Ayurveda Condition: KAPALA-ROGAH, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dhaturapatra Kalka lepa |
Prachanna followed by Dhaturapatra kalka lepa once in 4 days for one month. |
| Intervention |
Gokshuradi lepa |
Prachanna followed by Gokshuradi lepa once in 4 days for one month. |
|
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Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Alopecia areata [ Indralupta] anywhere in the scalp |
|
| ExclusionCriteria |
| Details |
•Subjects with other form of Alopecia areata like Alopecia totalis and Alopecia universalis.
•Alopecia due to other scalp disorders like Tinea capitis, Trichotillomania, Tillogen effluvium and Traumatic alopecia.
•Subjectswith endocrine disorders eg: Hypothyroidism.
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
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Method of Concealment
|
Case Record Numbers |
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Blinding/Masking
|
Participant Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
Gradings,
number of patches
measurement of patchy hair loss
skin texture over patchy hair loss |
60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Gradings
measurement of the patchy hair loss
number of patchy hair loss
skin texture over patchy hair loss |
3 months |
|
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Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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
|
N/A |
|
Date of First Enrollment (India)
|
16/01/2021 |
| 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="3" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - soundaryareddy13@gmail.com
- For how long will this data be available start date provided 05-06-2021 and end date provided 05-06-2026?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
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Brief Summary
|
Alopecia areata is a dermatologic disease characterized in its limited form by circumscribed round or oval patches of alopecia with well-demarcated borders between normal and affected scalp, there is no scale or induration of the scalp and no loss of follicular markings.1 As per the recent statistical data, Alopecia areata affects 0.1 to 0.2% of human population. It occurs in bothmale and female. It is most common in children and early adults. It is seen that an incidence of Alopecia areata tends to be higher when associated with diseases affecting the immune system affecting like asthma, allergies, atopic dermal aliments and hypothyroidism. In modern system of medicine, the treatment for hair fall has been showing less encouraging results, management is with corticosteroids internally and externally. Minoxidile, UVR, laser therapy,hormonal therapy and hair transplantation,etc. Even though this type of conventional management is effective, it has got some side effects and also the cost of these treatments are high. This is an attempt to find outa better, affordable and cost effective treatment for Indralupta which is also free from side effects. Alopecia areata is correlated with Indralupta in Ayurveda. It is characterized by sudden loss of hair from scalp. Pitta associated with Vata gets localized in the Roma kupa and causes the hair fall, later onKapha doshais associated with Rakta causes the obstruction to the hair roots and restricts their re growth.2 Prachanna helps in clearing the obstructed romakupas and vitiated rakta is expelled out. Prachanna drains out the vitiatedblood from the srotas and later when lepa is applied over the region it facilitates easy and faster absorption of the drug. Lepa applied over the scalp will be absorbed by the hair follicle which causes the pore’s to open up and helps in the growth of healthy hair. Ashtangahrudaya explains Daturapatra lepa for Indralupta in Shiroroga pratishedha adyaya3and Madhava chikitsa explains gokshuradhi lepa.4both the drugs are readily available and cost effective, hence chosen for the study.
HYPOTHESIS: NULL HYPOTHESIS H0 : There is neither effect of Prachanna with Gokshuradi lepa nor Dhatura patra lepain the management of indralupta.
ALTERNATE HYPOTHESIS : H1 : Prachanna with Gokshuradi lepa has significant effect than Dhatura patra lepa in the management of indralupta. H2 : Prachanna with Dhatura patra lepa has significant effect than Gokshuradi lepa in the management of indralupta.
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