FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/09/094336 [Registered on: 08/09/2025] Trial Registered Prospectively
Last Modified On: 04/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical study to assess and compare the effectiveness of injection therapy and apamarga kshara karma (an Ayurvedic procedure)in patients with piles(hemorrhoids). 
Scientific Title of Study   A clinical study to eveluvate the efficacy of injection therapy and apamarga kshara in 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 UDAYAN BHADRA 
Designation  POST GRADUATE 
Affiliation  Institute 
Address  DEPARTMENT OF PG STUDIES IN SHALYA TANTRA KVG AYURVEDA MEDICAL COLLEGE AND HOSPITAL, AMBATE ADKA, SULLIA, D.K. DISTRICT -574327 KARNATAKA

Dakshina Kannada
KARNATAKA
574327
India 
Phone  9488038376  
Fax    
Email  udayanbhadra4@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr SAHANA S 
Designation  ASSOCIATE PROFESSOR 
Affiliation  Institute 
Address  DEPARTMENT OF PG STUDIES IN SHALYA TANTRA KVG AYURVEDA MEDICAL COLLEGE AND HOSPITAL, AMBATE ADKA, SULLIA, D.K. DISTRICT -574327 KARNATAKA

Dakshina Kannada
KARNATAKA
574327
India 
Phone  8722613431  
Fax    
Email  drjois@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr UDAYAN BHADRA 
Designation  POST GRADUATE 
Affiliation  Institute 
Address  DEPARTMENT OF PG STUDIES IN SHALYA TANTRA KVG AYURVEDA MEDICAL COLLEGE AND HOSPITAL, AMBATE ADKA, SULLIA, D.K. DISTRICT -574327

Dakshina Kannada
KARNATAKA
574327
India 
Phone  9488038376  
Fax    
Email  udayanbhadra4@gmail.com  
 
Source of Monetary or Material Support  
KVG AYURVEDA MEDICAL COLLEGE AND HOSPITAL, AMBATE ADKA, SULLIA, D.K. DISTRICT -574327, KARNATAKA, INDIA.  
 
Primary Sponsor  
Name  Dr UDAYAN BHADRA 
Address  KVG AYURVEDA MEDICAL COLLEGE AND HOSPITAL, AMBATE ADKA, SULLIA, D.K. DISTRICT -574327 KARNATAKA  
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 UDAYAN BHADRA  KVG AYURVEDA MEDICAL COLLEGE AND HOSPITAL, SULLIA.  DEPARTMENT OF PG STUDIES IN SHALYA TANTRA, KVG AYURVEDA MEDICAL COLLEGE AND HOSPITAL, AMBATE ADKA, SULLIA, D.K. DISTRICT -574327 KARNATAKA, INDIA.
Dakshina Kannada
KARNATAKA 
9488038376

udayanbhadra4@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE, KVG AYURVEDA MEDICAL COLLEGE AND HOSPITAL, AMBATE ADKA, SULLIA, D.K. DISTRICT -574327 KARNATAKA  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K928||Other specified diseases of the digestive system. Ayurveda Condition: ARSAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-kShAra-karma, क्षार-कर्म (Procedure Reference: Sushruta samhita, Procedure details: Application of apamarga kshara & observation for 14 days)
2Intervention ArmProcedure-Injection therapy (Procedure Reference: NICE Guidelines (UK, 2010; updated 2023), Procedure details: Injecting almond oil with 5% phenol to the pile mass & observation till 14 days )
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Patients above 18yrs and below 70 yrs of age.
2. Presence of signs and symptoms of Arshas.
3. No discrimination of gender, chronicity or socio economic status.
4. Patient ready to participate and sign the informed written consent.
 
 
ExclusionCriteria 
Details  1. Patients below 18 yrs and above 70 yrs of age.
2. Patients with other serious systemic disorders
3. Contra-indications of Kshara Karma.
4. Contra-indications of Injection Therapy.
5. Pregnant and lactating women.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To analyse the reduction in size of arshas, pain and difficulty while defecation,   2 WEEKS(14 DAYS) 
 
Secondary Outcome  
Outcome  TimePoints 
Improving the quality of life in patients diagnoised with arshas  AFTER 14 DAYS 
 
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 
Date of First Enrollment (India)   01/10/2025 
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="0"
Days="0" 
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  

Arshas which is compared to haemorrhoids in the contemporary science is the commonest   ano-rectal condition seen in the practice of proctology. The dilated veins within the anal canal in the sub-epithelial region formed by radicles of superior, middle and inferior rectal veins are called as Haemorrhoids. Incidence of this disease can be traced since Vedic period. Its incidence increases with advancing age, at least 50% of people over the age of 50 years have some degree of haemorrhoidal symptoms. Now a day’s most of the persons suffer from any one of the complaints of piles during their life time.

The ancient medical authorities like Acharya Charaka and Acharya Sushruta both have described four types of measures for the treatment of Arsha. These are Bheshaja, Kshara, Agni and Shastra. Acharya Sushruta speaks much about Kshara, Agni, Shastrakarma. While going through the chapter of treatment of the disease Arshas, it becomes quite evident that Kshara Karma has been indicated for all the varieties of Arshas, that even the pedunculated and Arsha of a very big size can also be successfully treated with the help of Kshara Karma. Hence the repeated advocacy of Kshara Karma by almost all the ancient Acharya in the disease Arshas has given an inspiration to work on the disease Arsha with the help of Pratisaraneeya Kshara, because of its simple technique and it has important properties like Chedana, Lekhana, Ropana.

Pratisaraneeya Kshara described as an upakrama, substitute for surgical instruments, can be used safely in patients who are afraid of surgery. The detailed description of many Kshara preparations are available in Susruta Samhitha.

According to modern surgery haemorrhoids, which are not treated properly or neglected, may lead to complication such as strangulation, thrombosis, portal pyaemia, suppuration, haemorrhage etc. The management of haemorrhoids in modern medical science is changing from conventional surgical procedure i.e., Haemorrhoidectomy to other procedures like Injection Therapy, Rubber band ligation, Cryosurgery, Laser therapy etc. Injection therapy is a form of sclerotherapy, where 5% Phenol with Almond oil is injected submucosally causing fibrosis in submucosal region and thereby fixation of the anal cushions which do not prolapsed.

Hence an effort is made to compare and evaluate the efficacy of Injection therapy and Apamarga Pratisaraneeya Kshara in Arshas.

 
Close