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CTRI Number  CTRI/2022/10/046374 [Registered on: 11/10/2022] Trial Registered Prospectively
Last Modified On: 10/10/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Surgical/Anesthesia 
Study Design  Single Arm Study 
Public Title of Study   Role of Mochras coated ksharsutra in the management of Arsha i.e internal haemorrhoids. 
Scientific Title of Study   A Clinical study to evaluate the efficacy of Mochras ksharsutra in the management of Arsha ( IInd & IIIrd degree internal haemorrhoids) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rajiv Soni 
Designation  Assistant Professor and PhD Scholar 
Affiliation  UPGIASR 
Address  PG Department of Shalya Tantra university post graduate institute of ayurved studies and research DSRRAU Karwad Jodhpur

Jodhpur
RAJASTHAN
342037
India 
Phone  8209643872  
Fax    
Email  rajivsoni10@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rajesh Kumar Gupta  
Designation  Associate Professor and HOD 
Affiliation  UPGIASR 
Address  PG department of Shalya Tantra university post graduate institute of ayurved studies and research, Karwad

Jodhpur
RAJASTHAN
342037
India 
Phone  9636520573  
Fax    
Email  guptadrrajeshkumargupta@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Rajesh Kumar Gupta  
Designation  Associate Professor and HOD 
Affiliation  UPGIASR 
Address  PG department of Shalya Tantra university post graduate institute of ayurved studies and research, Karwad

Jodhpur
RAJASTHAN
342037
India 
Phone  9636520573  
Fax    
Email  guptadrrajeshkumargupta@gmail.com  
 
Source of Monetary or Material Support  
PG Department of Shalya Tantra University Post Graduate Institute of Ayurved Studies and Research DSRRAU Nagaur Road NH 62 Karwad Jodhpur Rajasthan Depty director of government ayurved department, N.G.O. or any other institute. 
 
Primary Sponsor  
Name  University Post Graduate Institute of Ayurved Studies and Research DSRRAU  
Address  PG Department of Shalya Tantra University Post Graduate Institute of Ayurved Studies and Research DSRRAU Nagaur Road NH 62 Karwad Jodhpur Rajasthan 342037 
Type of Sponsor  Research institution and hospital 
 
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 Rajiv Soni  University Post Graduate Institute of Ayurved Studies and Research Jodhpur  PG Department of Shalya Tantra (OPD NO 14) University Post Graduate Institute of Ayurved Studies and Research Jodhpur
Jodhpur
RAJASTHAN 
8209643872

rajivsoni10@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee University Post Graduate Institute of Ayurved Studies and Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K625||Hemorrhage of anus and rectum. Ayurveda Condition: ARSAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-kShArasUtra, क्षारसूत्र (Procedure Reference: chakkra dutta arshobhagandaram 5/148, Procedure details: Mochras coted kshar sutra Para Surgical Procedure)
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1 Patient will be selected randomly, irrespective of sex, economical status and education.
2 Patients attended with the classical signs and symptoms of Arsha ( IInd & IIIrd degree internal Haemorrhoids).
3 Patients who will be ready to give written informed consent. 
 
ExclusionCriteria 
Details  1 Patients with other systemic illness like uncontrolled Diabetes mellitus, malignancy etc.
2 HBsAg and Retrovirus positive patients.
3 Secondary internal haemorrhoids because of other systemic disorders.
4 Internal hemorrhoids with other associated Ano-rectal diseases / Colon diseases.
5 Infective and Neoplastic conditions of rectum/Anus.
6 Rectal prolapse, Pelvic pathology and Pregnancy. 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1 Raktasrava (Bleeding per rectum)
2 Prolapse of the pile mass.
3 Pain (Anal Discomfort)
4 Mucoid Discharge.
5 Rate of sloughing of pile mass.
 
1 Raktasrava (Bleeding per rectum)
2 Prolapse of the pile mass.
3 Pain (Anal Discomfort)
4 Mucoid Discharge.
5 Rate of sloughing of pile mass.
 
 
Secondary Outcome  
Outcome  TimePoints 
1 Recovery time.
2 Time to return to work.
3 Length of Hospital Stay.
4 Parental/patient satisfaction.

 
8 weeks 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   01/11/2022 
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   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

 (Ano-rectal region).Symptoms of Aabhyantara Arsha closely resemble to the clinical features of Internal Haemorrhoids. Arsha is being described by all the classical texts of Ayurveda. Acharya Sushrutaand Vagbhataeven placed this disorder in the “ASHTA MAHAGADA”,  (Eight grave diseases). It gives trouble to the person like as an enemy which was explained by Acharyas.

National Center for Health Statistics Johanson and Sonnenberg found that 10 million people in United States complained of Haemorrhoids, Prevalence rate of 4.4 %. In both sexes, a peak inprevalence was noted from age 45–65 yr, with a subsequent decrease after age 65 yr. The development of haemorrhoids before age 20 yr was unusual. A recent prospective study of screening colonoscopy patients revealed the presence of haemorrhoids in 38.9%, with 44.7% of those patients suffering from haemorrhoidal symptoms.

Acharya Sushruta has Arsha (Haemorrhoids) is one of the commonest ailments occurring in Guda Pradesha described four principle therapeutic measures in treating the Arsha. They are Aushadhi (Medicinal), Ksharkarma (Chemical cauterization), Agnikarma (Thermal cauterization) and Shastrakarma (Surgical excision). Sushruta speaks much more about Kshara Karma while going through the chapter for treatment of “Arsha”, it becomes quite evident that Kshara Karma has been considered as the most successful, simple and non-invasive para-surgical measure.

Here I am evaluating the efficacy and advantages of Mochras ksharsutra Ligation in  the Management of Arsha (2nd& 3rd degree internal Haemorrhoids).

•           Ayurveda is well known for the treatment of Arsha with Ksharsutra Ligation, due to yielding negligible rate of recurrence, cost effective, lesser pain, no bleeding, no infection, no anal incontinence and requiring minimal hospitalization during treatment with better recovery. Mochras i.e gum of salmalia Malabarica is easily available drug, can keep for longer period ,very safe to use and used to reduces the side effect of kshar karm i.e pain, Bleeding, Prolapse of the pile mass, burning sensation,,discharge ect. while snuhi sheer is difficult to available, can’t keep for longer period, unsafe and many side effects.

   Hence to check the quality of MOCHRAS explained by Charak, Sushruta, Bhavprakash ect. Mochras ksharsutra is made for treatment of Arsha (haemorrhoids). Thus present study has been planned.

    The aim of the present study is to develop more simplified and ideal therapy with addition of more healing effect and to reduce early & late post operative complication with less discomfort to the patient regarding Bleeding, pain, Prolapse of the pile mass, burning sensation, discharge ect. and Premature sloughing of pile mass. Mochras is safe and easily available drug .Hence  Mochras ksharasutra will be  prepared for ligation

 

 
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