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CTRI Number  CTRI/2023/08/056160 [Registered on: 04/08/2023] Trial Registered Prospectively
Last Modified On: 01/08/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical trail to study two pratisarneeya kshara , jala yukta nimba pratisarneeya kshara and gomutra yukta nimba pratisarneeya kshara in patients of abhyantara arshas(internal haemorrhoids). 
Scientific Title of Study   Comparative clinical study on the effectiveness of jala yukta nimba pratisarneeya kshara and gomutra yukta nimba pratisarneeya kshara in the management of abhyantara 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 Rahul Dogra 
Designation  Pg scholar- Department of Shalyatantra 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan 
Address  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, BM Road Thanniruhalla Hassan, Karnataka

Hassan
KARNATAKA
573201
India 
Phone  8360630523  
Fax    
Email  dograrahul886@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Prasanna Narasimha Rao 
Designation  Principal and Professor- Department of Shalyatantra 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan 
Address  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, BM Road Thanniruhalla Hassan, Karnataka

Hassan
KARNATAKA
573201
India 
Phone  9448064277  
Fax    
Email  profpnrao@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Prasanna Narasimha Rao 
Designation  Principal and Professor- Department of Shalyatantra 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan 
Address  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, BM Road Thanniruhalla Hassan, Karnataka

Hassan
KARNATAKA
573201
India 
Phone  9448064277  
Fax    
Email  profpnrao@gmail.com  
 
Source of Monetary or Material Support  
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan 
 
Primary Sponsor  
Name  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan 
Address  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital,BM Road, Thanniruhalla, Hassan, Karnataka,India - 573201  
Type of Sponsor  Private 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 Rahul Dogra  Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital, Hassan  Department of shalya tantra opd no 11( ano rectal opd ) . Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital,BM Road, Thanniruhalla, Hassan, Karnataka, India - 573201
Hassan
KARNATAKA 
8360630523

dograrahul886@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital, Hassan , Karnataka 573201  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,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-kShArakarma, क्षारकर्म (Procedure Reference: Sushruta samhita, Procedure details: The Participant will be taken to lithotomy position. The part is cleaned with aseptic solutions. Draping done before local anesthesia administration. Dilatation of anal canal after lubricating the finger with lignocaine jelly. Arshoyantra smeared with Taila is to be introduced into the anus. Assess the Haemorrhoids. The pile mass should be gently cleaned with cotton swab with Normal Saline. Then the gomutra Yukta Nimba Kshara will be applied with the help of Darvimukha Shalaka. After applying th)
2Comparator ArmProcedure-kShArakarma, क्षारकर्म (Procedure Reference: Sushruta samhita, Procedure details: The Participant will be taken to lithotomy position. The part is cleaned with aseptic solutions. Draping done before local anesthesia administration. Dilatation of anal canal after lubricating the finger with lignocaine jelly. Arshoyantra smeared with Taila is to be introduced into the anus. Assess the Haemorrhoids. The pile mass should be gently cleaned with cotton swab with Normal Saline. Then the jala Yukta Nimba Kshara will be applied with the help of Darvimukha Shalaka. After applying the k)
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Arshas which are of Mridu(soft), Prasrita(spreaded), Avagadha(deep), Uchrita (elevated).
2. First and second degree internal Haemorrhoids
3. Participants above the age of 18 years and below 70 years irrespective to gender, religion and socio-economic status. 
 
ExclusionCriteria 
Details  1. Participants with carcinoma of rectum and anal canal
2. External Haemorrhoids and interno-external Haemorrhoids
3. Patients with other systemic illness like IBS, Ascites, HBsAg positive & HIV positive.
4. Uncontrolled Diabetes (HbA1C >8).
5. Pregnant and lactating women.
6. Participants with impaired cardiac, renal and hepatic function. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Size of pile mass
2. Colour of Haemorrhoids
 
28 days
 
 
Secondary Outcome  
Outcome  TimePoints 
1. Pain
2. Constipation
3. Bleeding 
28 days  
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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 3 
Date of First Enrollment (India)   15/08/2023 
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="2"
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  
The disease which gives maximum trouble to mankind like an enemy is Arshas (Haemorrhoids). Sedentary life style, busy schedule of work, stress and bad food habits gives arises to Arshas. The primary etiological factor for the same is Mandagni.
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. Nowadays most of the persons suffer from any one of the complaints of piles during their life time.
In India 75% of population is estimated to be suffering from Haemorrhoids. Among this almost half million’s population are experiencing condition’s that are related to Haemorrhoids. Usually many are not aware that they have a symptom associated to this condition.
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. In modern medical sciences Haemorrhoids are treated with injection-Sclerosant therapy, Barron’s bandage, Cryosurgery, Infrared coagulation, DGHAL, Stapled haemorrhoidopexy second degree Haemorrhoids mainly treated with Barron’s band ligation and early second degree Haemorrhoids treated with injection therapy. Unfortunately, all these techniques have got one or the other types of limitation.
The ancient medical authorities like Acharya Charaka and Acharya Sushruta both have described four types of measures for the treatment of Arshas. These are Bheshaja, Kshara, Agni and Shastra. As per the available treatment modalities of Arshas, the Kshara Karma modality is the best one, taking into the consideration its convenience, easy adoptability, cost effectiveness and curative results.
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 Arshas 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 Arshas with the help of Pratisarneeya Kshara, because of its simple technique and it has important properties like Chedana, Bhedna, Lekhana.
Nimba has Krimighna and Arshoghna properties and have chemical constituents like nimbidin, nimbidol, sodium-nimbinate which helps in antimicrobial action. Anal canal is prone to contamination during postoperative period because of which there will be delaying of Ksharadagdha Vrana Ropana. Nimba is abundantly available, with a single plant we can get a large amount of Kshara. So, Nimba is selected for the Pratisarneeya Kshara in Abhyantra Arshas.
Nimba Pratisarneeya Kshara having properties like Sheeta Veerya, Tikta and Kashaya Rasa acts on haemorrhoids by cauterising the pile mass, due to its Teekshna Kshara Guna and coagulates protein in haemorrhoidal plexus.
Gomutra is important part of Indian tradition. It is not only holy but also has various important medicinal uses. Classical treatises in Ayurveda that is Charaka, Sushruta and Vagbhata Samhita has described Ashta mutra (eight types of urine) along with their properties, indication and uses. Cow urine is one of them and considered as best. Cow urine is one of the five contents of Panchagavya which obtain from cow (urine, milk, ghee, curd and dung).
Wound infection is a common cause of wound chronicity. It prolongs the inflammatory phase by increasing the production of inflammatory cytokines which lead to additional tissue destruction as well as delays wound collagen synthesis. Therefore, preventing wound infection would hasten process by promoting collagen synthesis. Various studies have demonstrated that cow urine (Gomutra), as well as its distillate, has antibacterial and antifungal activity against various strains of pathogens .
Till now, studies have been carried out by the use of Jala Yukta Apamarga, Chitraka, Nimba, Aragwadha and Palasha Kshara in various centers in India but less attention has been paid to Gomutra Yukta Kshara.
So, considering the above points it is very much essential to conduct a comparative study on Jala Yukta and Gomutra Yukta Nimba Pratisarneeya Kshara Karma.
 
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