| CTRI Number |
CTRI/2025/02/081235 [Registered on: 24/02/2025] Trial Registered Prospectively |
| Last Modified On: |
17/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Leech Therapy for Hair Regrowth: A Clinical Study on Alopecia Areata in Adults (18-40 Years) |
|
Scientific Title of Study
|
Randomized controlled clinical trial to evaluate the efficacy of Jalaukavacharana (Leech therapy) in the management of Indralupta w.s.r. 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 Shweta Bandu Pandhare |
| Designation |
MS Shalya Tantra Scholar |
| Affiliation |
Dr VJD Gramin Ayurved Mahavidyalaya Patur Akola |
| Address |
OPD no 18
Department of Shalya Tantra
Dr VJD Gramin Ayurved Mahavidyalaya near Renuka Mata Mandir, Patur
Tq. Patur
Dist. Akola
Akola MAHARASHTRA 444501 India |
| Phone |
9503007496 |
| Fax |
|
| Email |
shwetapandhare1999@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Gayatri Dipak Mawale |
| Designation |
MS Shalya Tantra Professor and HOD Shalya Tantra |
| Affiliation |
Dr VJD Gramin Ayurved Mahavidyalaya Patur Akola |
| Address |
OPD no 18
Department of Shalya Tantra
Dr VJD Gramin Ayurved Mahavidyalaya near Renuka Mata Mandir, Patur
Tq. Patur
Dist. Akola
Akola MAHARASHTRA 444501 India |
| Phone |
9850500860 |
| Fax |
|
| Email |
gayatriakola@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Gayatri Dipak Mawale |
| Designation |
MS Shalya Tantra Professor and HOD Shalya Tantra |
| Affiliation |
Dr VJD Gramin Ayurved Mahavidyalaya Patur Akola |
| Address |
OPD no 18
Department of Shalya Tantra
Dr VJD Gramin Ayurved Mahavidyalaya near Renuka Mata Mandir, Patur
Tq. Patur
Dist. Akola
Akola MAHARASHTRA 444501 India |
| Phone |
9850500860 |
| Fax |
|
| Email |
gayatriakola@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr VJD Gramin Ayurved Mahavidyalaya near Renuka Mata Mandir, Patur
Tq. Patur
Dist. Akola
Maharashtra, India
444501 |
|
|
Primary Sponsor
|
| Name |
Department of Shalya Tantra Dr VJD Gramin Ayurved Mahavidyalaya near Renuka Mata Mandir Patur Akola |
| Address |
Dr VJD Gramin Ayurved Mahavidyalaya near Renuka Mata Mandir, Patur
Tq. Patur
Dist. Akola
Maharashtra, India
444501 |
| 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 Shweta Bandu Pandhare |
Dr VJD Gramin Ayurved Mahavidyalaya Patur Akola |
OPD no 18 Department of Shalya Tantra Dr VJD Gramin Ayurved Mahavidyalaya, Patur
Tq.Patur
Dist. Akola
Maharashtra
India
Akola MAHARASHTRA |
9503007496
shwetapandhare1999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Dr VJD Gramin Ayurved Mahavidyalaya Patur Akola |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L639||Alopecia areata, unspecified. Ayurveda Condition: KSHUDRAROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | jalaukAvacaraNam, जलौकावचरणम् | (Procedure Reference: Sushrut Samhita Sutrasthan Adhyay 13 , Procedure details: Jalauka is locally applied i.e. called Jalaukavacharana .
Nirvish jalauka i.e Medicinal leeches i.e. Hirudo medicinalis will be collected.
These jalauka will be applied on bald patches at scalp for 04 times on Day 0, Day 7, Day 14 & Day 21.)
| | 2 | Comparator Arm (Non Ayurveda) | | - | Minoxidil 5% solution | Topical application of Minoxidil 5% solution 1-2 ml once a day. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients showing classical symptoms and sign of Indralupta as
described in ayurvedic samhitas.
2. Bald patch present only on scalp.
3. Bald patch size upto 3cm.
4. Upto 4 bald patches.
5. Patients between the age of 18-40 years.
6. Patients will be selected who are willing to give informed consent and
ready to comply with protocol.
7. Patients will be selected irrespective of gender, marital status, religion,
educational and economical status. |
|
| ExclusionCriteria |
| Details |
1. Patients are not willing.
2. Pregnant and lactating mothers.
3. Psychological disorders
4. Patients under the age of 18 and above 40years.
5. Patients with Bleeding disorders.
6. Patients with chronic Anemia.
7. Patients diagnosed with AIDS, HbsAg.
8. Bald patch present on body other than scalp.
9. Bald patch size more than 3cm.
10. Bald patch more than 4.
11. Patients having serious dermatological disorder of scalp |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Symptoms like 1) Hairfall
2) Smooth patches on scalp
will be decreased and control over Indralupta with reference to Alopecia areata |
7 days, 15 days, 21 days after starting treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Decrease in Symptoms of Indralupta |
18 Months |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
05/03/2025 |
| 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) |
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
|
Hair disorder cause negative impact towards the individuals and their quality of life. Indralupta is a Kshudraroga characterized by patchy loss of hair. It can be correlated with Alopecia Areata (AA) an autoimmune disorder characterized by the appearance of non scarring bald patches affecting the hair bearing areas of the body especially on scalp without any clinical signs of inflammation. Scalp is the most common site of involvement. AA can affect any age group. The usual pattern of hairloss is oval or round and can be correlated with Indralupta in Ayurveda. Indralupta (Alopecia) a dermatological disorder is of great concerns to male, female as well as children too, which can also cause psychological stress. Tendency of hair fall has been increased since last two decades and hair loss in children comes to approximately 3% of all pediatric cases. Ayurveda is effective and harmless treatment for this disease. Sushruta has mentioned Indralupta as Raktapradoshaja Vikara. Pitta associated with Vata gets lodge in Romakupa and causes hairfall, later on kaphadosha associated with Rakta causes obstruction to the hair roots & restricts the regrowth. Raktamokshana is a technical term employed to denote a para surgical procedure to expel out the vitiated blood from Selected areas of the body, by specific methods. Acharya Sushruta propounds practical guidelines for bloodletting and claims it as most effective therapy in half of the body ailments. Among various methods for bloodletting such as Jalaukavacharana karma, Pracchhana. Karma & Siravedha karma, Jalaukavacharana karma (Leech therapy) is considered as the ideal method to expel out the vitiated blood safely, quickly & effectively. Jalaukavcharan helps in draining the vitiated Rakta, in turn plays an important role in samprapti vighatana of Indralupta. |