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CTRI Number  CTRI/2025/10/095517 [Registered on: 01/10/2025] Trial Registered Prospectively
Last Modified On: 30/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Study on causes of Hair Loss (Alopecia Areata)and comparing Leech Therapy with herbal paste versus Platelet Rich Plasma Therapy for hair regrowth 
Scientific Title of Study   A Cross-Sectional Survey of Raktadushti Hetu in Indralupta (Alopecia Areata) and Evaluation of the Efficacy of Jalauka Avacharana with Lepa against Platelet-Rich Plasma Therapy: An Open-Label Randomized Comparative Trial 
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 Akriti 
Designation  MD Scholar,Department of Roga Nidana Evam Vikriti Vigyana  
Affiliation  All India Institute of Ayurveda 
Address  Room No.311, 3rd floor, Academic Block,Block C, Department of Roga Nidana Evam Vikriti Vigyana , All India Institute Of Ayurveda, Gautampuri, Sarita Vihar, Mathura Road New Delhi

South
DELHI
110076
India 
Phone  8278731881  
Fax    
Email  as17nice@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vivek Agarwal 
Designation  Additional Professor and HOD (Department of Roga Nidana Evam Vikriti Vigyana) 
Affiliation  All India Institute of Ayurveda 
Address  Department of Roga Nidana Evam Vikriti Vigyana, Room No.313, 3rd floor, Academic Block,Block C, All India Institute Of Ayurveda, Gautampuri, Sarita Vihar, Mathura Road New Delhi

South
DELHI
110076
India 
Phone  9416608598  
Fax    
Email  drvivek91@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Akriti 
Designation  MD Scholar, Department of Roga Nidana Evam Vikriti Vigyana  
Affiliation  All India Institute of Ayurveda 
Address  Room No.311, 3rd floor, Academic Block,Block C, Department of Roga Nidana Evam Vikriti Vigyana , All India Institute Of Ayurveda, Gautampuri, Sarita Vihar, Mathura Road New Delhi

South
DELHI
110076
India 
Phone  8278731881  
Fax    
Email  as17nice@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Ayurveda, Gautampuri, Sarita Vihar, Mathura road New Delhi 110076 
 
Primary Sponsor  
Name  All India Institute of Ayurveda 
Address  All India Institute of Ayurveda, Gautampuri, Sarita Vihar, Mathura Road New Delhi 110076 
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 Akriti  All India Institute of Ayurveda New Delhi  Room no. 311, Departmemt of Roga Nidana Evam Vikriti Vigyana, 3rd floor, Academic Block,Block C and pathology laboratory,1st floor, Hospital Block ,All India Institute of Ayurveda, New Delhi 110076
South
DELHI 		 08278731881

as17nice@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  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: KHALITYAM/KHALATI,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-jalaukAvacaraNam, जलौकावचरणम् (Procedure Reference: 21. Kumari K, Dixit RL, Dixit R. A conceptual study on Jalouka Avacharana. World J Pharm Med Res. 2022;8(5):123–5, Procedure details: Leech therapy will be administered in three sittings at intervals of three weeks. The patient will be positioned either prone or sitting to expose the scalp. Healthy leeches (Nirvisha Jalauka), activated in turmeric water, will be applied to the bald patch after local stimulation with Triphala Churna. If the leech does not attach, mild irritation with milk or a small scratch will be used. Once bloodletting occurs, the leech will be removed by applying Saindhava Lavana if needed, and post-care will include wound cleaning with Yashtimadhu and Haridra Churna. Leeches will be properly cleaned, made to vomit the sucked blood, and monitored before reuse.)
(1) Medicine Name: Gunja, Reference: B.R.60/61, Route: Topical, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: od, Duration: 14 Days
(2) Medicine Name: Brahmi, Reference: B.P Purvakhanda 4/237, Route: Topical, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: od, Duration: 14 Days
2Comparator Arm (Non Ayurveda)-Platelet-Rich Plasma TherapyAutologous Platelet Rich Plasma will be prepared from the venous blood of patient and injected intradermally in a dose of 0.1 to 0.2 ml per injection approximately1 cm apart in interfollicular area . Each patient will recieve 3 sessions of PRP treatment
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1 Patients having clinical features of Indralupta, hair loss in patches occurring anywhere on the scalp.
2 Patients of Indralupta with documented exposure to Raktadushti Hetu , as identified by validated questionnaire.
3 Patch less than 10 cm in diameter.
4 Number of patches 5 or less than 5.
5 Platelet count more than or equal to 1.5 lacs per microlitre.
6 Patient with Alopecia Areata willing for the procedure Platelet-Rich Plasma therapy and Jalauka Avacharana. 
 
ExclusionCriteria 
Details  1 Patients who have been diagnosed with Arunshinka and Alopecia like Tinea Capitis, Trichotillomania, Telogen Effluvium, Traumatic Alopecia
2 Patients suffering from severe endocrine or systemic disease like Carcinoma, SLE, Hypertension, Hypothyroidism, Diabetes Mellitus
3 Patients taking Chemotherapy and on blood thinning medications.
4 Patient with Unstable Angina
5 Blood disorder like anemia, Platelet Dysfunction, Active Infections
6 Lactating and pregnant women.
7 Patient with history of Keloidal tendency.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1 Prevalence of Raktadushti Hetu in Indralupta
2 Reduction in SALT 2 Score 		 Baseline(Day 0),Day 22(week 3),Day 42(week 6), Day 56(Week 8) 
 
Secondary Outcome  
Outcome  TimePoints 
1 Reduction in size of patch
2 Reduction in number of patches 		 Change in hair density from baseline to 6 weeks, quantified by trichoscopic hair count and standardized clinical photographic assessment. 
 
Target Sample Size   Total Sample Size="68"
Sample Size from India="68" 
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)   05/01/2026 
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 Applicable 
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   Alopecia Areata (AA), a frequent kind of Non-Scarring Alopecia affecting the body and/or scalp, is characterized by circumscribed , circular areas of hair loss , 2-5 cm in diameter  that is devoid of any symptoms of inflammation. Alopecia Areata affects about 2 percent of the world’s population and 0.7 percent in India.In Ayurveda , Indralupta is understood as a Pitta-dominant Tridoshjanya Vyadhi , involving imbalances in Vata , Pitta , Kapha Dosha and Rakta Dushya . Pitta along with Vata by involving the Romakoopa causes the fall of hairs and thereafter Shleshma along with Shonita obstructs the channel of Romakoopa leading to the stoppage of the regeneration of the hair and this condition is known as Indralupta (Alopecia Areata).Treatment of Alopecia Areata is challenging, and hair loss may remit naturally, although spontaneous hair regrowth may take months to years . Traditional therapeutic modalities include Corticosteroids, Immunosuppressants, Topical Immunotherapy, and Light Therapy . Several new treatments are under investigation, including IL-2 agonist, IL-17 inhibitors, Abatacept, JAK  inhibitors and Platelet-Rich Plasma (PRP). PRP is autologous preparation of platelets in concentrated plasma.It contains more than 20 growth factors.

NEED OF STUDY 

  • The exact etiopathogenesis of Alopecia Areata is yet unknown. This research will offer an explanation regarding the prevalence of Raktadushti Hetu in Alopecia Areata, providing some preliminary evidence on  Ayurvedic perspective .
  •  In contrast to Platelet-Rich Plasma Therapy, there isn’t enough scientific data to assess the therapeutic effectiveness of Jalauka Avacharana along with Gunja and Brahmi Lepa. This research is required to  assess both treatments and offer an evidence-based comparison. 

AIM AND OBJECTIVES

AIM :

To assess the prevalence of Raktadushti Hetu in patients with Indralupta and to evaluate the therapeutic  efficacy of  Platelet-Rich Plasma (PRP) Therapy and  Jalauka Avacharana combined with Gunja and Brahmi Lepa .

  OBJECTIVE :

      OBSERVATIONAL STUDY :

·       To document the prevalence of Raktadushti Hetu among patients attending AIIA OPD, by employing a validated assessment questionnaire.

      INTERVENTIONAL STUDY :

           PRIMARY OBJECTIVE

·       To compare the therapeutic effect of Jalauka Avacharana  in combination with Gunja Lepa and Brahmi Lepa with Platelet-Rich Plasma (PRP) Therapy in the management of Indralupta (Alopecia Areata) in terms of SALT II score .

SECONDARY OBJECTIVE

·       To assess the impact of these treatment modalities on hair growth and overall clinical improvement in patients with Indralupta (Alopecia Areata).

  •  OUTCOME MEASURES

  • PART 1 :

    Prevalence (%) of Raktadushti Hetu in patients with Indralupta .

    PART 2 :

    PRIMARY OUTCOME  :  Reduction in SALT II score    

    SECONDRY OUTCOME :

    ·       Reduction in size of patch

    ·       Reduction in the number of patches

    GROUPING : Participants diagnosed with Indralupta (Alopecia Areata) will be randomly allocated into two groups to compare the efficacy of Platelet-Rich Plasma (PRP) Therapy and Jalauka Avacharana (leech therapy) with sequential application of Gunja and Brahmi Lepa .

    GROUP A: PLATELET-RICH PLASMA THERAPY

    Patients in Group A will receive autologous PRP injections at intervals of three weeks. Each patient will undergo a total of three sittings. At each sitting, PRP will be prepared and injected into the affected scalp areas at a dose of 0.1–0.2 mL per injection site, following standard aseptic techniques.

    GROUP B: JALAUKA AVACHARANA WITH GUNJA AND BRAHMI LEPA

    Patients in Group B will receive Jalauka Avacharana at intervals of three weeks, with a total of three sittings. Following each Jalauka application, Gunja Lepa (as per area involved) will be applied topically over the affected scalp area for seven consecutive days, starting seven days after each Jalauka session. Subsequently, Brahmi Lepa (as per area involved) will be applied for the next seven days, immediately after the completion of Gunja Lepa application. This sequential Lepa protocol will be repeated after both the first and second Jalauka sittings.

 
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