| CTRI Number |
CTRI/2024/10/075031 [Registered on: 10/10/2024] Trial Registered Prospectively |
| Last Modified On: |
08/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
An ayurvedic management of alopecia areata |
|
Scientific Title of Study
|
A Comparative Clinical Study To Evaluate The Efficacy Of Indrayava Lepa And Dhattura Patra Lepa After Pracchana Karma In The Management Of Indralupta With Special Reference To Alopecia Areata |
| 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 Sushma R B |
| Designation |
PG Scholar |
| Affiliation |
Government Ayurveda Medical College, Bengaluru |
| Address |
Department Of PG Studies In Shalakyatantra,OPD No.11, Government Ayurveda Medical College, Dhanvantari road,
Bengaluru
Karnataka
560009
India
Bangalore
KARNATAKA
560009
India |
| Phone |
8217385880 |
| Fax |
|
| Email |
sushmarb57@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mamataj Begum Yadawad |
| Designation |
Assistant Professor |
| Affiliation |
Government Ayurveda Medical College, Bengaluru |
| Address |
Department Of PG Studies In Shalakyatantra, Government Ayurveda Medical College, Dhanvantari road,
Bengaluru
Karnataka
560009
Bangalore
KARNATAKA
560009
India |
| Phone |
9880466101 |
| Fax |
|
| Email |
mmyadawad@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sushma R B |
| Designation |
PG Scholar |
| Affiliation |
Government Ayurveda Medical College, Bengaluru |
| Address |
Department Of PG Studies In Shalakyatantra, Government Ayurveda Medical College, Dhanvantari road,
Bengaluru
Karnataka
560009
India
Bangalore
KARNATAKA
560009
India |
| Phone |
8217385880 |
| Fax |
|
| Email |
sushmarb57@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Sushma R B, PG Scholar, Department Of Shalakyatantra , Government Ayurveda Medical College, Dhanvantari Road, Bengaluru, Pincode-560009, Karnataka , India |
|
|
Primary Sponsor
|
| Name |
Dr Sushma R B |
| Address |
Madanayakanahalli , NH 50 road, Chitradurga District and Taluk, Pincode-577502 |
| 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 Sushma R B |
Government Ayurveda Medical College, Bengaluru |
Shalakyatantra OPD, Room No.11, Government Ayurveda Medical College, Dhanvantari Road, Bengaluru, Pincode-560009
Bangalore
KARNATAKA |
8217385880
sushmarb57@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Government Ayurveda Medical College, Bengaluru |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L639||Alopecia areata, unspecified. Ayurveda Condition: KAPALA-ROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | pracCAnam, पà¥à¤°à¤šà¥à¤›à¤¾à¤¨à¤®à¥ | (Procedure Reference: Sushruta Samhita Chikitsastana Chapter 20 ,Shloka No.24-26, Procedure details: Pracchana karma once in 7 days for 4 sittings followed by Dhattura patra lepa application
daily for 30 days)
(1) Medicine Name: Dhattura Patra Lepa, Reference: Ashtanga Hridaya Uttaratantra Chapter 24, Route: Topical, Dosage Form: Lepa Churna, Dose: 0(NA), Frequency: od, Duration: 1 Months | | 2 | Intervention Arm | Procedure | - | pracCAnam, पà¥à¤°à¤šà¥à¤›à¤¾à¤¨à¤®à¥ | (Procedure Reference: Sushruta Samhita Chikitsastana Chapter 20 ,Shloka No.24-26, Procedure details: Pracchana karma once in 7 days for 4 sittings followed by Indrayava lepa application daily for 30 days)
(1) Medicine Name: Indrayava Lepa, Reference: Basavarajeeyam 22nd Chapter, Route: Topical, Dosage Form: Lepa Churna, Dose: 0(NA), Frequency: od, Duration: 1 Months |
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1) Subjects having the clinical features of patchy hairloss occuring anywhere in the scalp.
2) Age group between 15-40 will be included.
3) Irrespective of gender.
4) Irrespective of size and number of patches on the scalp.
|
|
| ExclusionCriteria |
| Details |
1) Subjects with other form of Alopecia areata like Alopecia totalis and Alopecia universalis.
2) Alopecia due to other scalp disorders like Tinea capitis, Trichotillomania, Tilogen Effluvium and Traumatic alopecia.
3) Subjects with endocrine disorders eg: Hypothyroidism, Uncontrolled Diabetes. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) New Hair follicle growth on affected site
2) Reduction in the size of the bald spot
3) Reduction in the symptoms such as itching etc
|
58 days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) SALT Score
2) Pictorial presentation before and after treatment |
58 days |
|
|
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)
|
19/10/2024 |
| 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="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
|
Indralupta is one among the shiro kapalagata roga explained by Acharya Vagbhata and kshudra roga by Acharya Sushruta. It is characterized by patchy hair loss from scalp. It occurs when vitiated pitta associated with Vata gets localized in the roma kupa and causes the hairfall, later on kapha dosha in association with rakta, causes the obstruction to the hair roots and restricts their re growth. The symptoms of indralupta like patchy hair loss, restricted regrowth mimics Alopecia areata in modern science.
Alopecia areata is a dermatologic condition characterized in its limited form by circumscribed round or oval patches with well-demarcated borders between normal and affected scalp. As per the recent statistical data, Alopecia areata affects 0.1 to 0.2% of human population. It occurs in both male and female. It is most common in early adults. It is seen that an incidence of Alopecia areata tends to be higher when associated with diseases affecting the immune system.
In modern system of medicine, the treatment for Alopecia areata has been showing less encouraging results, as they are treating the condition with corticosteroids both internally and externally. Other treatment include Minoxidile, UVR, laser therapy, hormonal therapy and hair transplantation,etc, this type of conventional management is minimum effective, associated with some side effects and also the cost of these treatments are high. As hair is one’s crown and glory, hair disorders cause negative impact towards the individual’s quality of life. Hence, world is expecting treatment for this disease from other medical sciences.
So,in Ayurveda, both shodana and shamana treatment are indicated in Indralupta. Here, pracchana acts as shodana therapy, lepa acts as shamana therapy. Prachanna clears the obstructed romakupas, drains out the vitiated blood from the srotas and later when lepa is applied over the region it get absorbed by hair follicle which open up the pores thus facilitates easy and faster absorption of the drug and helps in the re-growth of healthy hair.
Basavarajeeyam, a famous treatise in Ayurveda, mentioned Indrayava lepa in the management of Indralupta, Acharya Vagbhata mentioned Dhattura patra lepa so, this study is planned to know the effectiveness of pracchana karma followed by Indrayava lepa and Dhattura patra application. Both Indrayava and Dhattura are readily available and cost effective ,hence chosen for the study.
HYPOTHESIS:
Null hypothesis:
H0: Indrayava lepa after Pracchana karma has no significant effect in Indralupta
Alternate hypothesis:
H1: Indrayava lepa after Pracchana karma has more effect than Dhattura patra lepa after Pracchana karma in Indralupta
H2: Indrayava lepa after Pracchana karma has less effect than Dhattura patra lepa after Pracchana karma in Indralupta
H3: Indrayava lepa after Pracchana karma and Dhattura patra lepa after Pracchana karma are equally effective in Indralupta
|