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CTRI Number  CTRI/2024/04/066343 [Registered on: 25/04/2024] Trial Registered Prospectively
Last Modified On: 26/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Diagnostic 
Study Design  Single Arm Study 
Public Title of Study   Ayurvedic Management of Vicharchika (Eczema) by Panchashirisha agada & Vishaghna lepa. 
Scientific Title of Study   Efficacy of Panchashirisha agada & Vishaghna lepa in the Management of Vicharchika w.s.r to Eczema - A Single arm Open-Labelled clinical 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  Jeel Umeshbhai Patel 
Designation  MD scholar 
Affiliation  Institute of Teaching and Research in Ayurveda 
Address  Department of Agadtantra, Ground floor,Dhanvantari mandir,ITRA Jamnagar, GUJARAT 361008 India

Jamnagar
GUJARAT
361008
India 
Phone  8160185191  
Fax    
Email  jeelptl5699@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sushant Sud  
Designation  Lecturer 
Affiliation  Institute of Teaching and Research in Ayurveda 
Address  Department of Agadtantra, Ground floor,Dhanvantari mandir,ITRA Jamnagar, GUJARAT 361008 India

Jamnagar
GUJARAT
361008
India 
Phone  9687792882  
Fax    
Email  drsud@itra.edu.in  
 
Details of Contact Person
Public Query  
Name  Vd Charmi Mehta  
Designation  Lecturer 
Affiliation  Institute of Teaching and Research in Ayurveda 
Address  Dep.of Kayachikitsa ,4th floor of itra academic building, ITRA Hospital ,OPP to B division police station ,Jamnagar 361008.

Jamnagar
GUJARAT
361008
India 
Phone  9428862264  
Fax    
Email  csmehta@itra.edu.in  
 
Source of Monetary or Material Support  
Institute of Teaching and Research in Ayurveda hospital,opp B division police station , P.N.Marg ,jamnagar,361008  
 
Primary Sponsor  
Name  Institute of Teaching and Research in Ayurveda 
Address  Institute of Teaching and Research in Ayurveda,Opp to B division police station Jamnagar,361008 
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 
DrJeel Umeshbhai Patel  Institute of Teaching & Research in Ayurveda hospital  Opd 19 ,Agadtantra dep, ITRA hospital ,Jamnagar,Opp B Devision Police station ,Jamnagar 361008
Jamnagar
GUJARAT 		 8160185191

jeelptl5699@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee,I.T.R.A., Jamnagar.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L249||Irritant contact dermatitis, unspecified cause. Ayurveda Condition: VICARCIKA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Panchashirisha agada, Reference: Carak samhita Chikitsa sthana 23/218, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(g), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 4 Weeks, anupAna/sahapAna: Yes(details: -Water), Additional Information: -
(2) Medicine Name: Vishaghna lepa, Reference: Carak samhita Sutra sthana 3/28, Route: Topical, Dosage Form: Kalka/ Paste , Dose: 10(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 4 Weeks, anupAna/sahapAna: Yes(details: Goghrita), Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients having Classical sign & Symptoms of vicharchika like Shyavta, Rukshta, Pidaka, Vedana, Daha.
2.Having recurrent hisory of Eczema.
3.Having Vicharchika with in duration of one year.
 
 
ExclusionCriteria 
Details  1.age below 18 & above 60 years.
2.Patients having Vicharchika more than the duration of one year.
3.Pregnant women.
4.Lactating mother
5.Patients suffering from Complicated systemic disease
6.Extensive infectious skin disorders ,Extensive dermatitis other than eczema.
7.patients who are willing for inclusion in the study. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Panchashirisha agada along with the Vishaghna lepa is effective in the management of Symtoms of Vicharchika(eczema)like Kandu,Pidaka,Shyavta,Daha,Rukshata,Vedana.  4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Study shall generate evidence based data in the context of improvement in the luster of the skin & colour of the skin.Hence,effectively improving the quality of life of patients.  4 weeks 
 
Target Sample Size   Total Sample Size="35"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   10/05/2024 
Date of Study Completion (India) 05/08/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 Pharmacognostic and Pharmaceutical Study of Panchashirisha Agada: A Novel Ayurveda Formulation 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

The present clinical study entitled “Efficacy of Panchashirisha Agada  and  Vishaghna Lepa  in the Management of Vicharchika w.s.r to Eczema - A Single arm Open-Labelled clinical trial was planned under the following sections.

                         

1.      Introduction:

      Vicharchika has been described under Kshudra Kustha, is a common skin disease described as Kapha pradhan Tridoshaja Vyadhi characterized by Kandu, Pidaka, Shyavata, Daha, Rukshata, Vedana which is similar to the Eczema in modern science. Disease have nature of recurrence which leads to significant morbidity & emotional stress which requires a effective and safer management so Ayurveda offers a holistic approach towards the disease    Panchashirisha Agada a classical Ayurvedic formulation mentioned in various classical texts, which is used as Sarvavishahara drug and Vishaghna Lepa having Shirisha & Sindhuwara is also used as Sarvavishaghna, but the both the drugs having properties such as Kandughna, Kushthaghna, Twakdoshahara, Varnya, Vishaghna, these formulations comprises multiple constituents with documented pharmacological activities, including anti-allergic, anti-inflammatory, immunomodulatory, antioxidant and anti-histaminic properties.

      The present clinical study aimed to evaluate the the clinical efficacy of   Panchashirisha  Agada  administered  internally along with  external application of  Vishaghna Lepa  in the management of Vicharchika (eczema) and to perform analytical profile of Panchashirisha Agada & Vishaghna Lepa.

 

2.      Pharmacognostical  Study

This study was carried out to verify the authentication of the both the trial drugs to validate its quality standards. The evaluation was carried out by studying the organoleptic parameters & microscopic characters of prepared formulations, Panchashirisha Agada Vati & Vishaghna Lepa at the Pharmacognostic Laboratory of ITRA, Jamanagar. Organoleptic evaluation revealed a Greyish-Black colour, Smooth texture & Characteristic Rasa and Gandha of Panchashirisha Agada & Brownish-Black colour, Smooth to touch Characteristic Gandha of Vishaghna Lepa. Microscopic Evaluation revealed diagnostic elements of both the drugs Shirisha & Sindhuwara like Stone cells, Rhomboidal crystal, Scleroids, Trichome, Crystal Fiber, Cork cell, Starch grains.

 

3.     Pharmaceutical Study:

In the present clinical trial both the Formulation was prepared at the Pharmacy of ITRA, Jamnagar as per the SOP. Physicochemical evaluation done at the pharmaceutical Laboratory of ITRA, Jamnagar, Loss on Drying of Panchashirisha Agada Vati was 12.80% & Vishaghna Lepa was 20.48% which indicates lower microbial contamination. Ash value of Panchashirisha Agada Vati was 30% & Vishaghna Lepa was 18% which exhibited amount of inorganic residue left over after burning. The normal extractive value of both the drugs suggesting moderate presence of water in both the formulations.   Panchashirisha Agada Vati having 8 pH value and Vishaghna Lepa having pH value of 6 which is mildly alkaline in nature. The Hardness of Vati  was 5.01 kg/cm2 indicating good mechanical resistance while handling or shipping and Deviation of vati were less than 5% proves uniformity of weight. These values are taken as standard for further studies of both the formulation as there is no standard available in API .

 

4.     Microbiological  Study

Microbiological evaluation was carried out to assess the stability and safety of both formulations with respect to microbial and fungal contamination over different time intervals and environmental conditions. Samples of Panchashirisha Agada Vati & Vishaghna Lepa were tested for 10 months under different climatic conditions. All samples showed no microbial growth except one sample of Panchashirisha Agada Vati, which showed mild growth of Escherichia coli due to high humidity and suboptimal storage. This isolated finding emphasizes the need for airtight storage and maintenance of low humidity, both the trial drugs remained microbiologically stable throughout the storage period and also demonstrated that the manufacturing process was sterile.

5.      Clinical Study

An open-labelled, Single-arm interventional clinical trial was conducted on 30 patients which were diagnosed with Vicharchika (eczema) at the OPD of Agad Tantra department, ITRA, Jamnagar, aged between 18 to 60 years. Ethical approval was obtained from the Institutional Ethics Committee (IEC No: PGT/7/A/Ethics/2023-24/2958), and the study was registered under the Clinical Trial Registry of India (CTRI/2024/04/064950).

A total 32 patients fulfilling the inclusion criteria were registered, of which two patients were dropped out during the study. Detailed documentation regarding demographic data, Subjective & Objective parameters done using specific research proforma. The assessment was done before & after the treatment and follow up.

6.      Observation

The majority of patients (34.38%) were between 31–40 years of age, followed by 28.13% in the 41–50 age group. Males (53.13%) slightly outnumbered females (46.88%). Most of the patients were Hindus (84.38%), married (90.63%), and educated up to higher secondary level (46.87%). Occupationally, housewives are at highest numbers (43.75%), followed by laborers (28.12%). Socioeconomically, 59.3% of patients belonged to the middle class, and 34.4% were from the lower middle class. A majority of patients resided in semi-urban (46.87%) and urban (43.75%) areas.

Clinically, all patients presented with Kandu (itching), Shyavata (discoloration), and Rukshata (dryness), each seen in 100% of cases. Daha (burning sensation) was observed in 53.12% of patients, while Pidaka (eruption) and Vedana (pain) were found in 37.5% each. Most patients (96.87%) reported a gradual onset of the disease, and only 12.5% had a positive family history. Regarding previous treatments, 62.5% had taken allopathic therapy, 6.25% Ayurvedic Shamana Chikitsa, and 3.12% Shodhana Chikitsa. A majority (68.75%) was vegetarians and 84.37% preferred home-cooked food. Assessment of Agni showed 31.25% patients with Mandagni and 28.12% with Vishamagni. Tea consumption was the most common addiction (71.87%). Regular bowel habits were observed in 78.12% of patients and 90.62% had normal sleep patterns. Emotionally, 59.37% were normal, 37.5% anxious, and 9.37% tense. Most patients (56.25%) had normal BMI, and 21.87% were obese. Pitta-Kaphaja Prakriti (56.25%) predominated among patients, followed by Vata-Pittaja.
In lesion characteristics, localized lesions (84.38%) were most common, followed by single (68.75%) and bilateral (59.38%) types. Lesions were highly distributed on the lower limbs (56.25%), followed by upper limbs (21.88%) and abdomen (15.63%). The majority of lesions had diffuse borders (90.62%) and were hyper pigmented in 59.37% of patients. Scaling lesions (46.88%) were most common, followed by papular (31.25%) and plaque lesions (25%).

7.      Result:
Therapeutic evaluation showed highly significant results. Subjective symptoms such as Kandu, Rukshata, Shyavata, Daha, Vedana, and Pidaka showed marked reduction, with percentage improvement ranging from 58.33% to 82.86%. Daha and Vedana showed the highest relief (above 80%). Objective parameters also revealed significant improvement—Number of patches reduced by 45.27%, and Area of patches decreased by 93.07%. The EASI score showed a 44.54% reduction, indicating significant recovery in disease severity. Hematological analysis showed a notable reduction in TLC (13.05%), monocytes (10.72%), and ESR (24.85%), reflecting anti-inflammatory activity, while other parameters like Hb and RBC remained stable, indicating safety of the formulation.

Overall effect of therapy: Overall, 60% of patients showed marked improvement, 23.3% had moderate improvement, and 16.7% achieved complete remission. No patient experienced adverse drug reactions or recurrence within one month of follow-up. The study concluded that the combined use of Panchashirisha Agada and Vishaghna Lepa was effective and safe in the management of Vicharchika (eczema), providing significant symptomatic relief and clinical improvement without any side effects.

8.      Discussion

In this research, the drugs were standardized through various parameters, including pharmacognostical, pharmaceutical, and analytical evaluations. The clinical aspect of the study, along with its observations and results, was carefully analyzed and interpreted using scientific reasoning.

 

9.      Conclusion

The conclusions were derived based on the observations and outcomes presented in the earlier sections. This part summarizes the overall findings of the study. Collectively, the insights gained from the literature review, pharmacognosy study, analytical study, clinical evaluation, and discussion contributed to drawing the final conclusions.


 
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