| CTRI Number |
CTRI/2025/11/096972 [Registered on: 06/11/2025] Trial Registered Prospectively |
| Last Modified On: |
05/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Jalaukavcharcha and Parisheka] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Management of Eczema with leech therapy and wash with medicated Khadira decoction |
|
Scientific Title of Study
|
Comparative clinical study to evaluate the effect of Jalaukavacharana and Khadira Kwatha Parisheka with Jalaukavacharana in Vicharchika w.s.r to Eczema |
| 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 Sourav Mahajan |
| Designation |
PG Scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda Hospital and Research Centre |
| Address |
Department of PG studies in Shalya Tantra General OPD no.5
Sri Dharmasthala Manjunatheshwara College of Ayurveda Hospital and Research Centre
Udupi
KARNATAKA
574118
India |
| Phone |
9888316609 |
| Fax |
|
| Email |
mahajansourav718@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prashanth k |
| Designation |
Professor |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda Hospital and Research Centre |
| Address |
Department of PG studies in Shalya Tantra General OPD no.5
Sri Dharmasthala Manjunatheshwara College of Ayurveda Hospital and Research Centre
Udupi
KARNATAKA
574118
India |
| Phone |
9448857560 |
| Fax |
|
| Email |
drp235@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sourav Mahajan |
| Designation |
PG Scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda Hospital and Research Centre |
| Address |
Department of PG studies in Shalya Tantra General OPD no.5
Sri Dharmasthala Manjunatheshwara College of Ayurveda Hospital and Research Centre
Udupi
KARNATAKA
574118
India |
| Phone |
9888316609 |
| Fax |
|
| Email |
mahajansourav718@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Sourav Mahajan
PG Scholar
Department of PG studies Shalya Tantra
Sri Dharmasthala Manjunatheshwara College of Ayurveda Hospital and Research Centre
Kuthpady, Udupi 574118 |
|
|
Primary Sponsor
|
| Name |
Dr Sourav Mahajan |
| Address |
Sri Dharmasthala Manjunatheshwara College of Ayurveda Hospital and Research Centre |
| Type of Sponsor |
Private medical college |
|
|
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 Sourav Mahajan |
Sri Dharmasthala Manjunatheshwara College of Ayurveda Hospital and Research Centre |
Department of PG studies in Shalya Tantra General OPD no.5
Sri Dharmasthala Manjunatheshwara College of Ayurveda Hospital and Research Centre, Kuthpady, Udupi 574118
Udupi
KARNATAKA |
9888316609
mahajansourav718@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC SDM College of Ayurveda kuthpady, udupi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L309||Dermatitis, unspecified. Ayurveda Condition: VICARCIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | pariSheka, परिषेक | (Procedure Reference: Sushruta Samhita Chikitsa Sthana Chapter 31 verse 6, Procedure details: One part of khadira bark is boiled in 4times of water, & reduced it to one fourth of water, it should be taken down from the fire and parisheka will be done in shrita sheeta state of kashaya. This procedure is done once daily over the lesion continuously for 7days).
Jalaukavacharana (Leech Therapy)- Poorva Karma (Before)- Take consent, check vitals, collect materials, activate leech in turmeric water, clean patient’s part. Pradhana Karma (During)- Apply leech on lesion during Pitta kala, cover with moist gauze, it sucks blood (detaches by itself or after 45 min). Paschat Karma (After)-Apply medicine & bandage, advise light diet, observe patient. Make leech vomit blood with salt/turmeric, store in separate jar (reuse after 1 month).)
(1) Medicine Name: Aarogyavardhini vati, Reference: Rasendrasarasangraha, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 350(mg), Frequency: tds, Duration: 21 Days(2) Medicine Name: Manjisthadhi Kwatha, Reference: Sahasra yoga, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 15(ml), Frequency: bd, Duration: 21 Days | | 2 | Comparator Arm | Procedure | - | jalaukAvacaraNam, जलौकावचरणम् | (Procedure Reference: Sushruta Samhita Sutra Santhana chapter 14, Procedure details: Jalaukavacharana (Leech Therapy)- Poorva Karma (Before)- Take consent, check vitals, collect materials, activate leech in turmeric water, clean patient’s part. Pradhana Karma (During)- Apply leech on lesion during Pitta kala, cover with moist gauze, it sucks blood (detaches by itself or after 45 min). Paschat Karma (After)-Apply medicine & bandage, advise light diet, observe patient. Make leech vomit blood with salt/turmeric, store in separate jar (reuse after 1 month))
(1) Medicine Name: Aarogyavardhini vati, Reference: Rasendrasarasangraha, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 350(mg), Frequency: tds, Duration: 21 Days(2) Medicine Name: Manjisthadhi Kwatha, Reference: Sahasra yoga, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 15(ml), Frequency: bd, Duration: 21 Days |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patient exhibiting signs and symptoms of Vicharchika (Eczema) as described in both classical Ayurvedic texts and modern medical literature |
|
| ExclusionCriteria |
| Details |
Patients contraindicated for Raktamokshana. Patients less than 16 years and above 70 years of age. Patients suffering from diseases like anaemia, hemorrhagic disorders, diabetes mellitus, cancer, tuberculosis, and other severe complicated systemic disorders will be excluded. Wide spread eczematous lesions involving more than 30 sq.cm. Eczema presenting with local or systemic signs of acute infection. |
|
|
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 |
| Patient will be relived from symptoms like itching, discolouration, eruptions and discharge. |
21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Itching
2. Discoloration
3. Eruptions
4. Discharge
5. Size of the lesion
|
21days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
21/11/2025 |
| 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="3"
Days="6" |
|
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
|
Skin is the chief wrap of the body, plays a chief role in maintaining barrier between internal and external environment. Ayurveda has described skin diseases under Kushtha. “Kushtha” literally means disfigurement of skin. Vicharchika is one of the Kshudra Kustha [1]. Clinical features of Vicharchika as explained in Charaka Samhita like itching, eruptions with excessive oozing matches the main clinical features of Eczema. Eczema apart from causing physical discomfort and disfigurement; disturbs the social and personal life of the patient and affects him psychologically. Management of Eczema is also quiet challenging for the physician due to its chronic protracted course. The prevalence of Eczema (also known as atopic eczema/dermatitis) is high, affecting up to 20% of children and up to 10% of adults. The burden of disease ranks 15th worldwide for non-fatal diseases, and number one for skin diseases, measured in disability-adjusted lifeyears (DALYs). [2] In the contemporary science treatment modalities includes corticosteroids, immunosuppressant and light therapy. [3] The corticosteroids give side effects like liver and kidney failure, bone marrow depletion, etc. The immunosuppressant gives side effects like hair loss, hypertension, diabetes, mouth sores, etc. While light therapy is generally considered safe and effective, it may carry potential side effects such as irritability. Additionally, the cost of treatment is often prohibitive for common people. The texts of Ayurveda consider Rakta Dusti as one of the prime causes of skin diseases [4]. Acharya Sushruta propounds practical guidelines for bloodletting and claims it as most effective therapy in half of the skin ailments [5]. Among various methods for bloodletting Jalaukavacharana (Leech therapy) is considered as the ideal method to expel out the vitiated blood safely, quickly, and effectively. According to the literature, Khadira Kwatha is considered best for skin diseases [6]. Khadira is characterized by its tikta and kashaya rasas, which help in balancing pitta and kapha doshas [7]. Due to its properties, Khadira is considered suitable for treating Vicharchika, which is primarily a Kaphaja disorder [8] associated with rakta dushti. It is readily available at an affordable cost. So, Jalaukavacharana along with Khadira Kwatha is considered to evaluate their efficacy along with oral medications in cases of Vicharchika (Eczema). |