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CTRI Number  CTRI/2024/08/072680 [Registered on: 19/08/2024] Trial Registered Prospectively
Last Modified On: 16/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Effect of Samasharkara Churna in the management of Haemorrhoids 
Scientific Title of Study   A clinical study to evaluate the effect of Samasharkara Churna in the management of Shushka Arshas 
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 Khamkar Anil Balu 
Designation  PG Scholar Department of Shalya Tantra  
Affiliation  Sri Jayendra Saraswathi Ayurveda College and Hospital 
Address  Department of Shalya Tantra, Room no.8, OPD block,Sri Jayendra Saraswathi Ayurveda College and Hospital,Nazarathpet, Chennai.

Thiruvallur
TAMIL NADU
600123
India 
Phone  9022810199  
Fax    
Email  anilkhamkar12@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr T Udaya Kiran 
Designation  Professor, Department of Shalya Tantram, PG studies 
Affiliation  Sri Jayendra Saraswathi Ayurveda College and Hospital 
Address  Department of Shalya Tantra, Room no.8, OPD block,Sri Jayendra Saraswathi Ayurveda College and Hospital,Nazarathpet, Chennai.

Thiruvallur
TAMIL NADU
600123
India 
Phone  9849666054  
Fax    
Email  dr_tenneti@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Anuroop I V 
Designation  Assistant Professor, Department of Shalya Tantram, PG studies 
Affiliation  Sri Jayendra Saraswathi Ayurveda College and Hospital 
Address  Department of Shalya Tantra, Room no.8, OPD block,Sri Jayendra Saraswathi Ayurveda College and Hospital,Nazarathpet, Chennai.

Thiruvallur
TAMIL NADU
600123
India 
Phone  9495763050  
Fax    
Email  dranuroopiv@gmail.com  
 
Source of Monetary or Material Support  
Sri Jayendra Sarawathi Ayurveda College and Hospital  
 
Primary Sponsor  
Name  Dr. Khamkar Anil Balu 
Address  Department of Shalya Tantra, Room no.8, OPD block, Sri Jayendra Saraswathi Ayurveda College and Hospital,Nazarathpet, Chennai TAMIL NADU, 600123 India.  
Type of Sponsor  Other [Self] 
 
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 Khamkar Anil Balu  Sri Jayendra Saraswathi Ayurveda College and Hospital  Department of Shalya Tantra, Room no.8, OPD block,Sri Jayendra Saraswathi Ayurveda College and Hospital,Nazarathpet Chennai. Thiruvallur TAMIL NADU 600123 India
Thiruvallur
TAMIL NADU 		 9022810199

anilkhamkar12@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Sri Jayendra Saraswati Ayurveda College and Hospital (Department of Ayurveda of SCSVMV Deemed to be University) NAZARATHPET, CHENNAI- 600123  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K649||Unspecified hemorrhoids. Ayurveda Condition: SUSHKA-ARSAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Samasharkara , Reference: Chakradatta Chi. 5/59, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Takra), Additional Information: Samasharkara Churna mixed with 250 ml of Takra and drink before food
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Subjects diagnosed with 1st and 2nd degree non-bleeding, non-mucous Hemorrhoids / Shushka Arshas 
 
ExclusionCriteria 
Details  1.Systemic conditions like Diabetes Mellitus, Diabetes Insipidus, Liver Cirrhosis and Portal Hypertension.
2.Subjects suffering from Raktaja, Pittaja and Rakta-Pittaja Arshas.
3.Pregnant women.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Pain during defecation and after defecation, bowel habits like constipation, Anal itching and burning sensation around the Anal region.
 		 4 Weeks
 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in Quality of Life  4 Weeks 
 
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 2/ Phase 3 
Date of First Enrollment (India)   30/08/2024 
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="4"
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   Modern days, a hectic lifestyle and a poor diet cause an imbalanced metabolism. It leads to Mandagni (low digestive power) which refers to the patient’s inability to digest the meal. It results in the accumulation of Aama, which upsets the Doshas in the anorectal region and causes Arshas. Haemorrhoids are the most common Anorectal disorders in the general population and also patients with Haemorrhoids are asymptomatic. In Ayurveda Bheshaja Chikitsa is a conservative and non-invasive treatment among the four Karmas, beneficial to cure at the initial stage or uncomplicated Piles. This study attempts to evaluate Samasharkara Churna’s effect in managing Shushka Arshas mentioned in Samhitas. Shushka Arshas occur due to the vitiated  Vata-Kapha Pradhana Dosha with Tvacha, Mamsa and Meda as Dushya. Ingredients of Samasharkara Churna are Shunthi, Pippali, Maricha, Nagakeshara, Patraka, Tvaka, Sukshma Ela with increasing order from first to last and addition of Khanda Sharkara in equal quantity within all ingredients and it is having properties of Arshoghna, Agnideepana, Rochaka, Kapha-Vatahara as well as Anti-inflammatory, Analgesic, Antioxidant properties. Khanda Sharkara also has Vatahara and Daha Shamaka properties and is used only as additives for maintaining taste. Its Anupana as Takram usually used in Apana Vata Dushti and enhances the balance of Agni.
 
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