Comparing the Effectiveness of Leech Therapy and Herbal Face Pack in Treating Facial Hyperpigmentation
- Conditions
- Other disorders of skin and subcutaneous tissue in diseases classified elsewhere. Ayurveda Condition: VYANGAH,
- Registration Number
- CTRI/2025/04/083989
- Lead Sponsor
- National Institute of Ayurveda Jaipur
- Brief Summary
**Prevalence-**Melasma is the skin disease which have high prevalence rate of 1.5% to 33.3%. In a Prospective study conducted on Indian male by Sarkar et al.in a tertiary care hospital in India, the prevalence of Melasma was found to be 20.5% in men. Melasma, however, affects women more commonly than men. An Indian study of 312 patients with Melasma found a 4:1 female to male ratio. Most common time of onset of Melasma was post pregnancy (42%), whereas 26% of patients developed it during pregnancy.
**NEED OF STUDY- T**herapeutic management of Melasma is challenging, with high recurrence rates which significant impacts on the quality of life. Systemic treatments with Tranexamic acid and polypodium leucomatous, etc. topical hydroquinone, Micro Needling, Peeling, and Laser have many side effects.These have potential drawbacks like irritation and rashes. Recurrence is also very high in these patients after discontinuation of the therapy. In Ayurveda, various studies have been carried out for the treatment of the *Vyanga*. These mainly focus on local medication/application like *Lepa*, *Taila* etc. *Vyanga* is a *Raktapradoshaj* *Vikara* therefore, vitiation of the *Rakta* *Dhatu* is the main event in the pathology. *Jalauka* is primarily used for *Raktamokshna* in the management of these diseases to alleviate *Rakta* *Dushti*. The role of *Jalaukacharana* in the management *Vyanga* is not studied till date. Therefore, this study is designed to compare the efficacy of of *Jalaukavacharana* and *Mukhakantikar* *Lepa* in *Vyanga* treatment.
**Research Gap Analysis-**There is no work done on comparative study of *Jalaukavacharana* and *Mukhakantikar* *Lepa* in *Vyanga*. To fill this knowledge gap, this study is planned.
**SELECTION OF DRUGS-**Ayurvedic treatment is conducted in two ways i.e. *Shamana* *Chikitsa* and *Shodhana* *Chikitsa*.
*Shamana* *Chikitsa* include *Prakshalana*, *Abhyanga*, *Lepana*, *Udvartana*, *Nasya*, *Rakta* *Mokshana*, etc. *Acharya* *Sushruta* has advised *Lepa*, *Shodhana* therapy, *Siravedha* *Karma* in Vyanga.
*Jalauka* are selected for the management of *Vyanga*. *Jalaukavacharana* is primarily employed in the *Dushti* of *Rakta* *Dhatu* by *Vata* and *Pitta* *Dosha*. *Jalauka* causes *Srotosodhana* locally by removing the deeply seated *Dosha* in the *Twacha*. Its help in subsiding all the associated symptoms of *Vyanga*. Pathological changes in *Pitta* *Dosha*, *Twak* *Vaivarnya* are produced in *Vyanga* *Roga*.
The drug *Manjistha* is mentioned in *Varnya* *Mahakashaya* in *Charaka* *Samhita*. Its stimulates *Dhatwagni*. Its *Kapha*-*Pittahara* properties pacify the aggravated *Kapha*, *Rakta*, and *Vata* *Dosha*. Also, it has a *Raktashodhaka*, *Kaphagna*, *Shothaghna*, *Kushthaghna,* etc. properties. *Vyanga* is characterised by *Shyava Varna Mandala* which decreases the luster of skin so *Manjistha* with properties like *Kashaya-Tikta-Madhura Rasa*, and *Varnya* becomes the drug of choice.
The selected drug for local application, *Mukhakanikar* *Lepa* contains *Yava*, *Yashtimadhu*, and *Lodhra*. These ingredients are *Madhura*, *Kashaya* in *Rasa*, *Sheeta* in *Virya*, which are *Pittashamaka* in *Guna*. All these ingredients are *Varnya*, *Pittashamaka*. According to *Acharya* *Sushruta*, the disease *Vyanga* is manifested due todisturbed state of *Vata* and *Pitta.* It is already proven effective in treating *Vyanga* in previous studies.
These ingredients are easily available and cost effective, so in this study *Manjistha* and *Mukhakantikar* *Lepa* are selected for the management of *Vyanga*.
***JALAUKAVACHARANA***
In Ayurveda, most of disease can be managed with *Shodhana* (bio-purification method), *Samshamananm* (pacification, palliative treatment) and *Nidana* *Parivarjanam* method.
For the *Rakta* *Pradoshaja* *Vyadhi*, *Raktmokshana* should be considered as the supreme method. *Aacharya* *Sushrut* mention the many benefit of *Raktmokshana*. It not only purifies the channels but also let the other parts become free from disease and its action is faster than other remedies.
**SELECTION OF LEECH:** *Yogya* *Jalauka* (*Nirvisha* *Jalauka*)
**STORAGE:** After collecting the *Jalauka* they should be kept in a wide and new pot filled with pool water and ooze or slime. On every second and third day the water should be changed and feeding should be dropped inside the pot. After five or seven days the pot should be changed.
***Jalaukavacharana*:** After collecting the leech, It will be Stored in clean fresh water jar and the water will be changed in every three or five days.every time for the new patient, fresh *Jalauka* will used and they were reused after 7 days.
**RESEARCH QUESTION-**Isthere any difference in the efficacy of *Jalaukavacharana* and *Mukhkantikar* *Lepa* in *Vyanga*?**HYPOTHESIS:**
**NULL HYPOTHESIS (H0):**There is no difference between the efficacy of *Jalaukavacharana* and *Mukhakantikar* *Lepa* in *Vyanga .*
**ALTERNATIVE HYPOTHESIS (H1)-**There is differencebetween the efficacy of *Jalaukavacharana* and *Mukhakantikar* *Lepa* in *Vyanga .*
**AIM-**To compare the efficacy of *Jalaukavacharana* and *Mukhakantikar* *Lepa* in *Vyanga*
**OBJECTIVES:**
**Primary objective**: To study the physiological concept of *Twak* focusing on *Vyanga* and to compare efficacy of *Jalaukavacharana* and *Mukhakantikar* *Lepa* along with *Manjistha* *Ghan* *Vati* in *Vyanga*
**Secondary objective**: To compare the efficacy of *Jalaukavacharana* and *Mukhakantikar* *Lepa* in *Vyanga*
**Material AND METHODS:**
**Study Design:**
Computerised Randomization
Comparative
Prospective
Interventional study
**Study Type:** Clinical Study
**Phase of Clinical Trail:** II
**Number of groups:** 2 groups
**Group A-** In 20 patients of *Vyanga-* *Jalaukavacharana* will be administrated once a week and*Manjistha Ghan Vati* 250 mg 2 BD will be given after meal (Luke warm water).
**Group B-** In 20 patients of *Vyanga* -*Mukhakantikar Lepa* OD (Base-Water) in morning and *Manjistha Ghan Vati* 250 mg 2 BD will be given after meal (Luke warm water).
**Site of Study:**
The study will be conducted in patients of *Vyanga* registered in OPD and IPD of National Institute of Ayurveda Hospital and SSBH, Jaipur.
**Study setting:**
OPD and IPD of National Institute of Ayurveda Hospital and SSBH, Jaipur. 40 patients of Vyanga will be randomly selected according to inclusion criteria from those who are visiting the OPD & IPD of National Institute of Ayurveda. Patients will be categorized into two groups, namely Group A and Group B, each group containing 20 patients. Informed written consent will be taken from the patients prior to commencement of the trial.
**Study Duration:** 18 months
**Ethical aspects**: Ethical clearance will be taken from Institutional Ethics Committee, National Institute of Ayurveda, Jaipur
**Participants of Interest:** Patient who are visiting in OPD and IPD of National Institute of Ayurveda Hospital and SSBH, Jaipur.
**Sampling method:** Convenience Sampling
**Sample size:**Total 40 patients. Group A (20) OR Group B (20)
Sample size calculation: At 95% confidence level and 80% power & using previous study data S.D.=3.53
Diff.of mean=1.76
Sample Size-42 for each group
But due to limited period of time (18 months) and budget the sample size of 20 for each group is fixed for the present study
**Screening criteria:** Patients of *Vyanga*who will fulfil the inclusion criteria irrespective of gender, religion, occupation and socio-economic status.
Patients who are diagnosed with *Vyanga* will be selected from the OPD and IPD of National Institute of Ayurveda Hospital and SSBH, Jaipur.
**Diagnostic criteria:**
The diagnosis will be made on the basic of Ayurveda as well as Modern aspect of signs and symptoms.
A special Proforma will be prepared to diagnose the patients of *Vyanga* as mentioned in classics.
**Withdrawal criteria:**
During the course of trial, if any serious illness or any adverse effects. appears which requires urgent treatment.
Patients himself/herself want to withdraw from the clinical trial.
**Referral Criteria:**
In the occasion of any adverse drug reaction or Adverse drug event.
**GROUPING:**
**Group A:** ***Jalaukavacharna* +*Manjistha* *Ghan* *Vati***
***Jalaukavacharana*-** One sitting per Week (total 8 sittings /7 days interval) will be given for 60 days.
***Manjistha* *Ghan* *Vati***-250mg (2 tab)/ BD, after meal with lukewarm water for 60 days.
**Group B:** ***Mukhakantikar lepa + Manjistha Ghan Vati***
***Mukhakantikar* *Lepa*:**
Thickness- 1/2 *Angula* *Pramana*/one time (base-water) applied in Morning.
Duration- *Lepa* Should not be removed before it gets dried.
***Manjistha* *Ghan* *Vati***-250mg (2 tab)/ BD, after meal with lukewarm water for 60 days.
**DURATION OF CLINICAL TRIAL AND FOLLOW UP STUDY:**
**Total Duration of Trial:** 60 days.
**Follow up during treatment:**
Assessment of the all subject will be done after each 15 days (on 0th day, 15th 30th 45th & 60th days) during the trial in both groups.
**Follow up after treatment:**
Post assessment will be done after 60th day on the basis of MASI score.
**CONCOMITANT TREATMENT: (if any) –**NA
**RESCUE MEDICATIONS:***Sphatika Bhasma,* + *Lodhra Churna* / *Yastimadhu* *Churna*
**INVESTIGATIONS:**
Investigations will be performed in Group A only before the *Jalaukavacharana* to rule out any systematic illness / bleeding disorders:
| | | |
| --- | --- | --- |
|**Name of Investigation**
**Purpose**
**Timings for investigation**
|CBC
For Screening
Before trial
|RBS
For Screening
Before trial
|C.T.
For Screening
Before trial
|B.T.
For Screening
Before trial
|HIV
For Screening
Before trial
|HBsAg
For Screening
Before trial
**ASSESSMENT CRITERIA:****MASI Score**
| | | |
| --- | --- | --- |
|**Area of patches:**
**Darkness:**
**Homogeneity**
|**0= no involvement**
**0=Absent**
**0=Normal skin color**
| **without evidence of hyperpigmentation**
|**1=<10**
**1=Slight**
**1=specks of involvement**
|**2=10-29**
**2=Mild**
**2=small patchy areas of**
| **Involvement < 1.5 cm**
|**3=30-49**
**3= Marked**
**3=Patches of involvement>2cm**
|**4=50-69**
**4= Severe**
**4=uniform skin involvement**
|**5=70-89**
|**6=90-100**
| **TOTAL**
**Forehead = 30%**
**Left malar= 30%**
**Right malar = 30%**
**Chin= 10%**
**Total = 100%**
MASI=0.3A (D+H) +0.3A(D+H) +0.3A(D+H) +0.1A(D+H)
***Varna Prasadana* (Change in texture, lustre of skin)**
| | |
| --- | --- |
|**Grade**
**Texture of skin**
|1
Rough
|2
Normal
|3
Smooth
| | |
| --- | --- |
|**Grade**
**Luster of skin**
|1
Non-lustrous
|2
Normal
|3
Unctuous
**STASTICAL ANALYSIS:**
The collected data will be analysed statistically using appropriate test.
**Descriptive statistics:** The information that is collected will be represented using mean, median, standard deviation, standard error and observations will be represented using Graphs and Tabular columns.
**Inferential statistics:**
For Intra group-Wilcoxon’s signed rank test
For Inter group-Mann Whitney’s U test
**DECLARATION:**
Enrolment of the patients for clinical trial will be started only after approval of ethics committee and registration of clinical trial with CTRI (Clinical Trial Registry of India). Any adverse drugs events/ reaction observed throughout the study period will be reported to Pharmacovigilance cell of National Institute of Ayurveda, Deemed to be University, Jaipur.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 40
- Patients with classical sign and symptoms characterized by Niruja painless Shyava Varna Mandala bluish black patches of Vyanga Melasma.
- Subjects with MASI Score ranges between 4 to 12.
- Patients who were ready to sign the consent form.
- Patients fit for Jalaukavacharana.
- Patients suffering from any severe systemic or any skin diseases other than melasma.
- Known case of any chronic systemic diseases sexually transmitted disease, diabetes mellitus hypertension any blood disorders or any organ failure.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in the grade of MASI (Melasma area severity index) score of Melasma. 60 days
- Secondary Outcome Measures
Name Time Method Varna Prasadna Change in texture, lustre of skin 15 days
Trial Locations
- Locations (1)
National Institute of Ayurveda
🇮🇳Jaipur, RAJASTHAN, India
National Institute of Ayurveda🇮🇳Jaipur, RAJASTHAN, IndiaDr Kalpana SahuPrincipal investigator9755017858kalpanasahu17858@gmail.com