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CTRI Number  CTRI/2025/07/092039 [Registered on: 30/07/2025] Trial Registered Prospectively
Last Modified On: 30/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   AYURVEDIC TREATMENT FOR HEMARRHOIDS 
Scientific Title of Study   COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF KUTAJA PRATISARANIYA KSARA AND KASISADI TAILA IN THE MANAGEMENT OF ARSAS HEMORROHOIDS  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Basammagari Amarnath 
Designation  Post graduate scholar 
Affiliation  S.V.Ayurvedic College and Hospital  
Address  Room no.41, second floor, PG department of Shalya tantra, S.V.Ayurvedic College and Hospital, Tirupati, Chittor, Andhra Pradesh

Chittoor
ANDHRA PRADESH
517507
India 
Phone  9652205100  
Fax    
Email  dramarnath006@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  T Srinivasa rao  
Designation  Associate Professor 
Affiliation  S.V.Ayurvedic College and Hospital  
Address  Room no.45, second floor, PG department of Shalya tantra, S.V.Ayurvedic College and Hospital, Tirupati, Chittor, Andhra Pradesh

Chittoor
ANDHRA PRADESH
517507
India 
Phone  9440601161  
Fax    
Email  dr.srinivasayu@gmail.com  
 
Details of Contact Person
Public Query
 
Name  T Srinivasa rao  
Designation  Associate Professor 
Affiliation  S.V.Ayurvedic College and Hospital  
Address  Room no.45, second floor, PG department of Shalya tantra, S.V.Ayurvedic College and Hospital, Tirupati, Chittor, Andhra Pradesh


ANDHRA PRADESH
517507
India 
Phone  9440601161  
Fax    
Email  dr.srinivasayu@gmail.com  
 
Source of Monetary or Material Support  
S.V.Ayurvedic College and Hospital Tirupati, Chittor, Andhra Pradesh 517507  
 
Primary Sponsor  
Name  S.V.Ayurvedic College and Hospital 
Address  Tirupati, Chittor, Andhra Pradesh 517507  
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 
Dr Basammagari Amarnath  S.V.Ayurvedic Hospital   Room no.41, second floor, PG department of Shalya tantra, S.V.Ayurvedic College and Hospital, Tirupati, Chittor, Andhra Pradesh
Chittoor
ANDHRA PRADESH 
9652205100

dramarnath006@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of TTDs S V Ayurvedic College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K641||Second degree hemorrhoids. Ayurveda Condition: ARSAH, (2) ICD-10 Condition:K642||Third degree hemorrhoids. Ayurveda Condition: ARSAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-picu, पिचु (Procedure Reference: Bhaisajya Ratnavali, Arshoroga Chikitsa prakaram chapter, Procedure details: It will be conduct according to the principle of trividha karma Poorva karma pre operative procedure Routine investigations will be check Fitness of patient will be check Written in form consent of patient `will be taken Shaving & cleaning of the peri anal region will be done. Pradhana karma: The patient will be laid down in lithotomy position The perianal part will be painted & draped with sterilized cut sheet Then lubricate the proctoscope, with the cut aperture will be introduced in the anal canal The pile mass is fixed at the suitable place into the aperture. After cleaning the pile mass with gauze piece, then Application of kaseesadi taila pichu dharana Paschat karma Ano rectal region will be applied with sterile gauze piece and pads )
(1) Medicine Name: Kāsīsadi taila , Reference: Bhaisajya Ratnavali, Arshoroga Chikitsa prakaram chapter, Route: Rectal, Dosage Form: Taila, Dose: 5(ml), Frequency: od, Duration: 8 Days
2Intervention ArmProcedure-pratisAraNIya-kShAraH, प्रतिसारणीय-क्षारः (Procedure Reference: Sushrut samhit , Cikitsā sthāna 6th chapter arsha chikitsitam 4th shloka, Procedure details: It will be conduct according to the principle of trividha karma Poorva karma: [ pre operative procedure] •Routine investigations will be check •Fitness of patient will be check •Written in form consent of patient will be taken •Shaving and cleaning of the peri anal region will be done. Pradhana karma: •The patient will be laid down in lithotomy position •The perianal part will be painted and draped with sterilized cut sheet •Then lubricate the proctoscope, with the cut aperture will be introduced in the anal canal The pile mass is fixed at the suitable place into the aperture. •After cleaning the pile mass with gauze piece, then apply the Kuṭaja Kṣāra. •Applied Kṣāra will be keep for 100 mātrā kāla. •After the application of the Kṣāra the pile mass changed to pakwajambuphala Varna [ripen fruit of Jamun fruit].it indicates the Samyak Kṣāra dhagda lakshana. •The Kṣāra is wash out with the nimbu swarasa. Paschat karma: • Madhu and ghrita will be applied to overcome the gudadāha [burning sensation]. • Ano rectal region will be applied with sterile gauze piece and pads. ) )
(1) Medicine Name: Kuṭaja Kṣāra,, Reference: Suśruta saṃhita. Sutrasthāna 11th chapter ksharapaka vidi adhyayam 11th shloka ,, Route: Rectal, Dosage Form: Kshara, Dose: 10(g), Frequency: od, Duration: 3 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients having signs and symptoms of Arsas
2.Patients with age ranging from 18 years to 60 years with irrespective of gender
3.Patients having II and III degree Hemorrhoids 
 
ExclusionCriteria 
Details  1.Concomitant ano rectal conditions like Fistula in ano, Fissure in ano
2.ulcerative colitis
3.Carcinoma of rectum
4.Pregnant women
5.Portal hypertension
6.Chronic kidney diseases
7.Tuberculosis on Anti tuberculosis treatment
8.Inflammatory bowel disease 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Evaluate the Efficacy of Kutaja Pratisaraniya Ksara with reference to objective and subjective parameters   At baseline, Every week for 2 weeks and after 2 months 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the Efficacy of Kutaja Pratisaraniya Ksara & Kasisadi Taila   At baseline, after 15 days,
after 2 months 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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   N/A 
Date of First Enrollment (India)   11/08/2025 
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="6"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [dramarnath006@gmail.com].

  6. For how long will this data be available start date provided 28-08-2025 and end date provided 28-01-2083?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  
Arshas has become one of the commonest health problems of the modern society. It is the foremost common disease among Anorectal disorders and the area of concern even since the Vedic periods. This disease causes discomfort and severe pain to the patient which creates problems in his daily routine. Because of its severity it is considered as one among Ashta Mahagada. As it is difficult to treat completely and because of its Svabhava which create problems to the patients as an enemy the name Arshas has been given. The food habits and life styles of modern man also added to the increase in the rate of incidence of Arshas.

             Present time is the era of changing food, sedentary life style and mental stress, all these factors disturbs the digestive system resulting into many diseases. Among them one important group is  Ano-rectal diseases and Arshas is one among them. Arshas have been known to mankind since long time and one of the commonest disease to effect the human being. One of its prime etiological factor is Mityaahara-Vihara. When we observe the today’s patients, we understand that they want quick relief but at the same time not interested to undergo surgery that may give severe post-operative pain. In such conditions the alternative is Kshara Karma procedure that gives relief and the pain is insignificant.

              The great Indian Surgeon Susrutha known as father of surgery has described Arshas in Susrutha samhita Nidana stana[5] 2nd chapter and its chikitsa in Chikitsa sthana 6th chapter . He considered Arshas as one of the Astha Mahagadas means diseases which are very difficult to treat. Arshas causes troublesome pain for patient like enemy, which afflicting mankind for thousands of years[7]. According to Madhavakara, the disease which kills a man like an enemy is called Arshas. The present lifestyle is adding to the prevalent rate of this disease.

              This condition can be correlated with Haemorrhoids in modern medical science, in which dilated veins within the anal canal in the sub epithelial region formed by radicals of superior, middle and inferior rectal veins. Haemorrhoids are engorgement of the Haemorrhoidal venous plexus, characterized by bleeding per rectum, constipation, pain, prolapse and discharge.

Depending on grade of prolapse , Haemorrhoids can be divided into 4 degrees :

1.                First degree     : Haemorrhoids within that may bleed but does not come out of anus. 

2.                Second degree : Haemorrhoids come out only during defecation and gets reduced      

                           Spontaneously. 

3.                Third degree    : Haemorrhoids come out only during defecation and do not return by themselves, but need to replaced manually and then they stay reduced.

4.                Fourth degree  : Haemorrhoids are permanently prolapsed with great discomfort and feeling of heaviness in the rectum[1]. 

 

             It is manifested due to improper diet, prolonged standing and faulty habits of defecation causing derangement of tridoshas, mainly vata dosha. Vitiated doshas localizes in gudhavali pradhana dhamani and mamsadhara kala and vitiates twak, mamsa and raktha, resulting in annavaha srotho dushti. These vitiated doshas moves in downward direction, reaches guda and produces sprouts of muscle in gudavali. These sprouts are called Arshas.

 

            In Charaka samhitha, Charakaacharya has given more emphasis on the conservative treatment and prescribed suitable diet regimen with drugs, further he also advised kshara karma treatment for different types of arshas.

            In Sushruta Samhita, Acharya Susrutha has mainly narrated the four types of treatment modalities in sushruta samhitha chikitsa sthana in Arshachikitsa for successful management of Arshas viz., Bhesaja [Internal and external medications], Shastra [Surgical methods], Kshara [Caustic cauterization], and Agnikarma [Thermal cauterization].[6]

 

             Susrutha, while describing the preparation of kshara, emphasized on the procedure of kshara karma and mentioned that arshas which are Mridu,Prasrutha,Avagadha,Uchrita should be treated only by kshara karma. The effect of kshara is praised so much that it can replace sastrakarma as it does the functions of Chedana, Bhedana, Lekhana karmas without using the sastras[surgical instruments]. Among the four treatment modalities in Arshas mentioned by susrutha, kshara karma and Agnikarma are considered as para-surgical procedures.

             Despite of many more modern treatments like Rubber band ligation, Sclerotherapy, Photocoagulation, Cryosurgery, Haemorrhoidectomy, etc., Ayurveda is well known for the treatment of Arshas for its negligible rate of recurrence, cost effective, less chances of pain, Haemorrhage, infection and anal incontinence.

            In Sushruta Samhita, Sutrastana  “Ksharapakavidi  adyaya” mentioned 23 kshara dravyas, Kutaja is the  first one among them[4]. Here I would like to prepare kshara with KUTAJA (bark), In  this clinical study kutaja kshara will be take into consideration for local application directly on the arshas.
 
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