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CTRI Number  CTRI/2023/10/058933 [Registered on: 20/10/2023] Trial Registered Prospectively
Last Modified On: 18/10/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To study the effect of Dadimsyrup and Nagakeshar churna in management of Raktarsha (Bleedig piles) 
Scientific Title of Study   A Randomized Comparative clinical trial to evaluate the efficacy of Dadima syrup in comparison with Nagkeshara choorna in the management of Raktarsha.”  
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 Avantika Anil Chintkuntlawar 
Designation  Pg Scholar 
Affiliation  PDEAs College of Ayurved and Research Centre,Nigdi Pune. 
Address  PDEAs College of Ayurved and Research Centre, third floor, Shalyatantra Department, Sector no 25, Pradhikaran Nigdi Pune

Pune
MAHARASHTRA
411044
India 
Phone  9022067488  
Fax    
Email  c.avantika04@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Madhavi Banarase 
Designation  Professor and H.O.D 
Affiliation  PDEAs College of Ayurved and Research Centre,Nigdi Pune 
Address  PDEAs College of Ayurved and Research Centre, third floor, Shalyatantra Department, Sector no 25, Pradhikaran Nigdi Pune

Pune
MAHARASHTRA
411044
India 
Phone  9423207569  
Fax    
Email  dr.madhavibanarase209@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Madhavi Banarase 
Designation  Professor and H.O.D 
Affiliation  PDEAs College of Ayurved and Research Centre,Nigdi Pune 
Address  PDEAs College of Ayurved and Research Centre, third floor, Shalyatantra Department, Sector no 25, Pradhikaran Nigdi Pune


MAHARASHTRA
411044
India 
Phone  9423207569  
Fax    
Email  dr.madhavibanarase209@gmail.com  
 
Source of Monetary or Material Support  
PDEAs College of Ayurved and Research Centre,Nigdi Pune 
 
Primary Sponsor  
Name  PDEAs College of Ayurved and Research Centre Nigdi Pune 
Address  PDEAs College of Ayurved and Research Centre, third floor, Shalyatantra Department, Sector no 25, Pradhikaran Nigdi Pune Maharashtra 411044 
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 Avantika Anil Chintkuntlawar  Ayurved Rugnalya and Sterling Multi-speciality Hospital, Nigdi Pune  Ayurved Rugnalaya and Sterling Multi-speciality Hospital , Shalyatantra Department, OPD No 123A Pradhikaran Nigdi Pune
Pune
MAHARASHTRA 		 9022067488

c.avantika04@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee college of ayurveda and Research centre Nigdi   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K929||Disease of digestive system, unspecified. Ayurveda Condition: RAKTAJA-ARSAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Nagakeshar Churna, Reference: Charak chikitsa 14/210, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 5 Days, anupAna/sahapAna: Yes(details: Sharkara), Additional Information: -
2Intervention ArmDrugClassical(1) Medicine Name: Dadimsyrup , Reference: Bhaishajya Ratnawali 9/149, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 25(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 5 Days, anupAna/sahapAna: No, Additional Information:
(2) Medicine Name: Dadimsyrup , Reference: Bhaishajya Ratnawali 9/149, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 25(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 5 Days, anupAna/sahapAna: No, Additional Information:
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patient irrespective of gender,caste,sex,religion,economical status

Raktarsha

Gudstrav,Gudkandu,Gudagatshool

 
 
ExclusionCriteria 
Details  Known Case Of

Hypertension , Diabeties

Thrombosed Piles
Major cardiac illness
Associated with other anorectal conditions like
Fistula in ano

Prolapsed of the rectum
Perineal Abscess

Malignancy

Ulcerative colitis
Rectal polyp
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To compare efficacy of DADIMSYRUP and NAGKESHARA CHOORNA in the management of Raktarsha ”  total Duration 5 days
follw up on - 1st, 3rd and 5th days of treatment 
 
Secondary Outcome  
Outcome  TimePoints 
NA  NA 
 
Target Sample Size   Total Sample Size="56"
Sample Size from India="56" 
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)   01/11/2023 
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="0"
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  
Haemorrhoids is one of the most common ano-rectal disease. Haemorrhoids also called piles,these are dilated veins within the anal canal.Fast food,disturbed bowel habits,sedentary life style ,shift duties,stressful life,being obese,straining during bowel movemants,prolong standing & sitting these are the causes of Haemorrhoids.
Prevelence of Haemorrhoids in India is 75% of the population.15

In Ayurveda we can correlate Haemorrhoids with Arsha.

Arsha is defined as:

अरिवत् प्राणान् शृणाति हिनस्ति ।
                       (मा.नि.मधुकोष टिका ५/१1)


अरिवत्प्राणिनो मांसकीलका विशसन्तियत् ।

अर्शांसि तस्मादुच्यते गुदमार्ग निरोधतः ||

                         (अ.हृ.नि.७/१2)

Arsha is called as destroyer of life like an enemy.
Arsha is a disease that causes death due to constant stabbing pain in the anus.

 Haemorrhoid is the most common cause for bleeding per rectum.
 Haemorrhoids are vascular structures in the anal canal they become a disease when swollen or inflamed.

 Haemorrhoids are classified into(on basis of location):
       (1)Internal Haemorrhoid
       (2)External Haemorrhoid

1) Internal Haemorrhoids
• Internal Haemorrhoids are located above the dentate line.
• Internal Haemorrhoids are usually painless because there are few pain sensitive nerve fibres are there in upper part of anal canal.
• Bleeding may be the only sign in internal haemorrhoids

2) External Haemorrhoids
• External Haemorrhoids are located below the dentate line.
• External Haemorrhoids are mostly painful because lower part of anus has pain sensitive nerve fibres.
 
Aggrevated doshas get localized in guda vali  through pradhan dhamani and vitiates twak,mans and meda dhatu and at the site of gudavali they produce Arsha.

Classification Of Piles
a)Acc to Acharya Sushrut6 13
1)Vataj 2)Pittaj 3)Kaphaj 4)Raktaj 5)Sannipataj 6)Sahaj

b)Acc to Acharya Charak
1)Shushka 2)Stravi

Stravi Arsha is also known as Aantarika or Raktarsha ie.Internal Haemorrhoids.
The most common symptom seen in internal Haemorrhoids is bleeding after going to toilet,Blood is usually fresh and dropwise not mixed with faeces.

 
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