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CTRI Number  CTRI/2022/04/041866 [Registered on: 13/04/2022] Trial Registered Prospectively
Last Modified On: 27/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   EFFICACY STUDY OF RAKTAMOKSHAN KARMA BY SIRAVEDHAN AND PRACCHAN IN THE MANEGEMENT OF VICHARCHIKA (ATOPIC DERMATITIS) 
Scientific Title of Study   A CLINICO-COMPARATIVE STUDY OF RAKTAMOKSHAN KARMA BY SIRAVEDHAN AND PRACCHAN IN THE MANEGEMENT OF VICHARCHIKA (ECZEMA) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  NEHA PATEL 
Designation  P G SCHOLAR 
Affiliation  GOVERNMENT AKHANDANAND AYURVEDA COLLEGE 
Address  OPD NO 5 PANCHAKARMA DEPARTMENT GOVERNMENT AKHANDANAND AYURVEDA COLLEGE BHADRA AHMEDABAD
OPD NO 5 PANCHAKARMA DEPARTMENT GOVERNMENT AKHANDANAND AYURVEDA COLLEGE BHADRA AHMEDABAD
Ahmadabad
GUJARAT
380001
India 
Phone  9016897297  
Fax    
Email  nehapatel989875@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  HEMANG RAGHAVANI 
Designation  LECTURER 
Affiliation  GOVERNMENT AKHANDANAND AYURVEDA COLLEGE 
Address  OPD NO 5 PANCHAKARMA DEPARTMENT GOVERNMENT AKHANDANAND AYURVEDA COLLEGE BHADRA AHMEDABAD
OPD NO 5 PANCHAKARMA DEPARTMENT GOVERNMENT AKHANDANAND AYURVEDA COLLEGE BHADRA AHMEDABAD
Ahmadabad
GUJARAT
380001
India 
Phone  9925008060  
Fax    
Email  vdhemang@gmail.com  
 
Details of Contact Person
Public Query
 
Name  HEMANG RAGHAVANI 
Designation  LECTURER 
Affiliation  GOVERNMENT AKHANDANAND AYURVEDA COLLEGE 
Address  OPD NO 5 PANCHAKARMA DEPARTMENT GOVERNMENT AKHANDANAND AYURVEDA COLLEGE BHADRA AHMEDABAD
OPD NO 5 PANCHAKARMA DEPARTMENT GOVERNMENT AKHANDANAND AYURVEDA COLLEGE BHADRA AHMEDABAD
Ahmadabad
GUJARAT
380001
India 
Phone  9925008060  
Fax    
Email  vdhemang@gmail.com  
 
Source of Monetary or Material Support  
GOVERNMENT AKHANDANAND AYURVEDA COLLEGE AHMEDABAD 
 
Primary Sponsor  
Name  GOVERNMENT AKHANDANAND AYURVEDA COLLEGE 
Address  OPD NO 5 GOVERNMENT AKHANDANAND AYURVEDA COLLEGE BHADRA AHMEDABAD 
Type of Sponsor  Government medical college 
 
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 
NEHA PATEL  GOVERNMENT AKHANDANAND AYURVEDA COLLEGE AHMEDABAD  OPD NO 5 PANCHAKARMA DEPARTMENT GOVERNMENT AKHANDANAND AYURVEDA COLLEGE BHADRA AHMEDABAD
Ahmadabad
GUJARAT 
9016897297

nehapatel989875@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L209||Atopic dermatitis, unspecified. Ayurveda Condition: ECZEMA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-sirAvedhaH, सिरावेधः (Procedure Reference: SUSHRUT SAMHITA, Procedure details: IN SIRAVEDHAN,VEIN IS PUNCTURED BY NEEDLE AND BLOOD COMES THROUGH THE TUBE INTO MEASURING GLASS. STANDARD PROTOCOL WILL BE FOLLOWED DURING KARMA AND PRECAUTIONS WILL BE TAKEN TO PREVENT SECONDARY INFECTIONS. SIRAVEDHAN KARMA ALONG WITH GANDHAK RASAYAN 5 GM ORALLY. (2 SITTING OF SIRAVEDHAN KARMA WITH THE GAP OF 15 DAY))
(1) Medicine Name: GANDHAK RASAYAN, Reference: AYURVED PRAKASH, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 5(g), Frequency: od, Duration: 4 Weeks
2Comparator ArmProcedure-pracCAnam, प्रच्छानम् (Procedure Reference: SUSHRUT SAMHITA, Procedure details: IN PRACCHAN,BY USING INSTRUMENT MULTIPLE INCISIONS ARE MADE OVER THE DISEASED AREA. STANDARD PROTOCOL WILL BE FOLLOWED DURING KARMA AND PRECAUTIONS WILL BE TAKEN TO PREVENT SECONDARY INFECTIONS. PRACCHAN KARMA ALONG WITH GANDHAK RASAYAN 5 GM ORALLY (2 SITTING OF PRACCHAN KARMA WITH THE GAP OF 15 DAYS))
(1) Medicine Name: GANDHAK RASAYAN, Reference: AYURVED PRAKASH, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 5(g), Frequency: od, Duration: 4 Weeks
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  RAKTAMOKSHAN YOGYA PATIENTS AND PATIENT HAVING SYMPTOMS OF VICHARCHIKA (ECZEMA) WITH FULL FILLING DIAGNOSTIC CRITERIA 
 
ExclusionCriteria 
Details  RAKTAMOKSHAN AYOGYA PATIENTS AND PATIENT HAVING THALESEMIA, HAEMOPHILIA, D.M, STD, AIDS,T.B,OTHER DISORDER WHICH LEAD TO FETAL CONDITION 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome
Modification(s)  
Outcome  TimePoints 
PRIMARY OUTCOME WILL BE ASSESSED ON THE BASIS IMPROVEMENT IN EASI SCORE.  2 WEEK 
 
Secondary Outcome
Modification(s)  
Outcome  TimePoints 
SECONDARY OUTCOME WILL BE ASSESSED ON THE BASIS OF IMPROVEMENT IN SYMPTOMS.  2 WEEKS 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "35"
Final Enrollment numbers achieved (India)="35" 
Phase of Trial   N/A 
Date of First Enrollment (India)   16/04/2022 
Date of Study Completion (India) 29/06/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 29/06/2023 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
NOT YET 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  
The clinical study was carried out in 35 patients of Vicharchika. from O.P.D. of Govt. Akhandanand Ayurveda college and hospital, Ahmedabad. Among all registered patients 30 patients completed the course of treatment and evaluated for improvements on signs & symptoms of Vicharchika. The observation charts with brief description of the both groups of treatments and obtained results along with the statistical analysis presented in the form of tables.
The data analysis of 35 patients of Vicharchika showed that 40% patients belonged to the age group of 31-40yrs, 51.43% were female, 97.14% were Hindu, 54.28% patients were graduate, 94.28% were married, 40% patients were housewife, 57.14% were belonged to lower middle class.
In Pradhana Vedana observation; Kandu, Vaivarnyata and Rukshata were observed in 100% patients, Raji observed in 94.3% patients, Daha observed in 37.14% patients, Pidika observed in 20% of patients and Strav observed in 2.8% patients. Majority 62.8% patients were having symptoms since 1-5yrs, 74.28% patients were having gradual onset, 48.57% patients had acute condition of disease, 97.14% patients were having Shushka type of Vicharchika, 80% patients were not having spreading nature of Vicharchika, 91.43% patients were not having family history, 60% patients were having allergic past history, 77.14% patients had allopathic medication for Vicharchika treatment.
In Ahara 77.14% patients were having veg. diet, 88.6% patients were having Katu-Amla Rasa Sevana, 45.71% patients were having Vishamagni, 57.14% patients were having irregular dietary habit, 40% patients had Samasana, 82.86% patients were addicted to tea, 68.57% patients had Samyaka Nidra, 77.14% patients were having regular bowel habit, 62.8% patients were Madhyama Koshthi, 74.28% patients were having normal mental status.
In Aharaj Nidana, in Viruddha Ahara; 65.71% patients were having fruit+Dugdha and 62.86% patients were having Khichadi+Dugdha. In Garishta Ahara; 60% patients had fermented food and 57.14% patients had curd preparation. In Asatmya Ahara; 80% patients were having garlic & onion, 74.28% patients were having new Annapana. In Viharaj Nidana; 45.71% patients were doing Vegadharana, 37.14% patients were using cold water for either Pan or Snana purpose and 37.14% patients had day sleep. In Manasika Nidana; 71.43% patients had Chinta and 14.28% patients had Shoka about their diseased condition.
In Dashavidha Pariksha, 60% patients were having Vata-Pitta dominance in Prakriti, 65.71% patients were having Raja-Tama dominance in Manasa Prakriti, 80% patients were having Madhyama Sara, 85.71% patients were having Madhyama Samhanan, 82.86% Madhyama Pramana, 85.71% patients were having Madhyama Satmya, 62.86% patients were having Avara Satva, 77.14% patients were having Madhyama Abhyavaharana Shakti, 54.28% patients were having Madhyama Jarana Shakti, 74.28% patients were having Avara Vyayama Shakti, 80% patients were belonged to Yuva Vaya, 97.14% were belonged to Sadharana Pradesh.
In lesion site, 82.8% patients were having lesion over lower extremities, 60% patients were having atopic type of eczema, 37.14% patients were having more than 4 lesions on the body, 54.28% patients were having lesion of 1-5cm in size, 51.43% patients were having disease in Sthanika part of body, 82.8% patients had asymmetrical pattern of lesion, 97.14% had 1 region score.

• EFFECT OF THERAPIES
1. Group A: Siravedhana Karma along with Gandhaka Rasayana
In this, group 17 patients were registered; 15 patients were completed the course of treatment (2 sitting of Siravedhana Karma with 15 days gap between each sitting along with Gandhka Rasayana orally 5gm/day in divided dose) and 2 patients were dropout.
Treatment provided highly significant result in Kandu, Raji and Vaivarnyata and not significant result in Pidika, Daha, Rukshata and Strav. In EASI criteria highly significant result observed in erythema, edema/papulation, excoriation and lichenification.
In overall assessment of group A, 26.67% patients had moderate improvement, 60% patients had mild improvement, 6.67% patients noted no improvement.
2. Group B: Pracchan Karma along with Gandhaka Rasayana
In this, group 18 patients were registered; 15 patients were completed the course of treatment (2 sitting of Pracchan Karma with 15 days gap between each sitting along with Gandhka Rasayana orally 5gm/day in divided dose) and 3 patients were dropout.
Treatment provided highly significant result in Kandu, Raji, Vaivarnyata, Daha and Rukshata and significant result was observed in Pidika. In EASI criteria highly significant result observed in erythema, edema/papulation, excoriation and lichenification.
In overall assessment of group B, 13.33% patients had marked improvement, 80% patients had moderate improvement, 6.67% patients had mild improvement.

Discussion
In this part the observations of study, trial drug mode of action, trial Karma mode of action and obtained result of both groups discussed with logical reasoning and brief description. Role of various factors and Nidana in Dosha Prakopa and manifestation of disease are discussed.

Summary & Conclusion
This part comprises summary of all conceptual and clinical study briefly. The conclusion and interpretation drawn through the basis of study.

CONCLUSION
A good conclusion is the determination established by investigation in various ways and it reviews the key points of dissertation and explain if the information is relevant, applicable or related to study as a whole.
From observation and found results followed point were obtained and concluded that:
Vicharchika, a type of Kshudra Kushtha; due to similarity in symptoms it can correlated with eczema. In Kushtha Chikitsa, Raktamokshana Karma is indicated as a line of treatment. In this study along with Raktamokshana Karma, Gandhaka Rasayana has been taken from Ayurved Prakash.
No side effect or adverse effect was observed in both groups in present study. The therapy is very effective in treating Vicharchika.
In this study null hypothesis (H0) and alternative hypothesis (H1) is rejected; alternative hypothesis (H2) accepted.
Alternative hypothesis (H2): Raktamokshana performed with Pracchan is more effective in compare to Siravedhana in the management of Vicharchika (Eczema).
On the basis of results of research study, it can be concluded that Pracchan Karma provides better result than Siravedhana in management of Vicharchika. It is due to maximum patients are having Alpa Sthangata Vicharchika and Pracchan Karma is mainly used to treat Alpa and Anavgadh Kushtha as per Samhita.

 
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