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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L639||Alopecia areata, unspecified. Ayurveda Condition: KSHUDRAROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-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.)
2Comparator 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.
 
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