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CTRI Number  CTRI/2020/09/028052 [Registered on: 25/09/2020] Trial Registered Prospectively
Last Modified On: 17/09/2020
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   Study of effect of Kalingadi Vati in piles 
Scientific Title of Study   A randomised clinical study for efficacy of Kalingadi Vati in the management of Arsha with special reference to 1st and 2nd degree 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 Deepali Ajitrao Kolnure 
Designation  PG student 
Affiliation  Ayurved Seva Sangh Ayurved Mahavidyalaya Nashik 
Address  OPD no 6 Shalyatantra Department

Nashik
MAHARASHTRA
422003
India 
Phone  9284202284  
Fax    
Email  kdeepalida@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vinay Sonambekar 
Designation  Professor and Guide 
Affiliation  Ayurved Seva Sangh Ayurved Mahavidyalaya Nashik 
Address  OPD No 6 Shalya Tantra Department

Nashik
MAHARASHTRA
422003
India 
Phone  9822624890  
Fax    
Email  sonambekar.chinmay@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Vinay Sonambekar 
Designation  Professor and Guide 
Affiliation  Ayurved Seva Sangh Ayurved Mahavidyalaya Nashik 
Address  OPD No 6 Shalya Tantra Department


MAHARASHTRA
422003
India 
Phone  9822624890  
Fax    
Email  sonambekar.chinmay@gmail.com  
 
Source of Monetary or Material Support  
Dr Deepali Ajitrao Kolnure Ayurved Seva Sangh Ayurved Mahavidyala Nashik Ganeshwadi Panchavati Nashik 
 
Primary Sponsor  
Name  Ayurved Mahavidyalaya Nashik 
Address  Ganeshwadi Panchavati Nashik 
Type of Sponsor  Other [State Govt Grant in aid Institute] 
 
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 Deepali Ajitrao Kolnure  Arogyashala Rugnalaya Nashik  OPD No 6 Shalya Tantra Department
Nashik
MAHARASHTRA 
9284202284

kdeepalida@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ayurved Seva Sangh Ayurved Mahavidyalaya Instutitional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Kalingadi Vati  500 mg twice daily before meal with lukewarm water for 30 days 
Comparator Agent  Pilex tabelt  1gm twice daily after meal with lukewarm water for 30 days 
 
Inclusion Criteria  
Age From  17.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patient having clinical features of Arsha
Agnimandya.
Saraktmalpravritti.
Malavshthambha.
Gudshool.
Gudkandu
 
 
ExclusionCriteria 
Details  Diagnosed case of Carcinoma of rectum large intestine rectal polyps prolapse of rectum fistula in ano crohns disease fissure in ano
Pregnant women and lactating mother
Patients having systemic diseases like liver cirrhosis portal hypertension
Severe anaemic patient
Bleeding disorders like haemophilia and purpura
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Decrease in bleeding tendancy
Relief in anorectal pain and inflammation
 
30 days
 
 
Secondary Outcome  
Outcome  TimePoints 
Relief in constipation
Relief in anorectal itching
Improvement in digestion  
30 days 
 
Target Sample Size   Total Sample Size="74"
Sample Size from India="74" 
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)   28/09/2020 
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  

According to Ayurveda apathya aahar, vihar leads to vatadi dosha dushti at the guda vali (anal region), pradhan dhamani (venous supply),mansadhara kala and vitiates twaka,mansa,rakta,meda resulting in annavaha strotas dushti,agnimandya and arsha

According to modern science, haemorrhoid is engorgement of haemorrhoidal venous plexus characterized by bleeding per rectum,constipation,pain,prolapseand discharge. A growing inclination for fast food, faulty food habbits, spicy junk foods, aerated cold drinks, low intake of fiber rich diet.Stressfulprofessions,busy lifestyle, constipation, insomnia that’s all affect the health of the body. Because of all these things constipation occurs. Long duration of constipation and prolonged straininglead to engorgement of veins in anal canal and gives birth to haemorrhoids.

In modern science, haemorrhoids have very limited options for treatment which are mostly different surgical modalities like Lord’s anal dilatation, Cryosurgery, laser haemorrhoidectomy, injection sclerotherapy, rubber band ligation etc. But arsha disease is mainly related to sedentary lifestyle and hampered digestive system.So even after the surgical treatment and modern conservative treatment there is probability of recurrenece andpostoperativepain is very troublesome. Anal stenosis and incontinence are deadful complaints. The cost of surgery is also relatively highso patients are not readily willing for surgery.

According to Sushrut Samhita and Vagbhata Samhita, there are four treatment modalities of arsha i.e. bhaishajchikitsa (internal medicine), kshara karma (chemical cauterization), Agnikarma (thermal cauterization) and shastra karma (surgicaltechnique). Agnimandya is the main etiological factor of arsha. One important effective formulation is kalingadi vati explained in Ashtangahrudaya. The ingredients of this vati are Kalinga,Langali,Pippali,Apamarga,Bhunimba etc. The properties of these dravyas leads to Agnideepana, Arshoghna, Pachan, Shothahar, Shoolghna and Sthambhan. Hence it can break down the samprapti of arsha disease. So we have decided to study the efficacy of kalingadivati in the management of arsha which is very cost effective and easily available. Ayurveda Samhita provide us the opportunity to treat arsha with cost effective medication instead of surgical procedure. Raktastrava and agnimandya is the main complaint of the patient in the arsha disease. According to ayurvedic Samhita there are two types of arsha that is Stravi and Astravi. Kalingadivati seems to be an ideal formulation which can cause Agnideepana also Raktstambhan.Tilldate no study has been conducted on kalingadivati.Therefore it was decided to take up this study.


 
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