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CTRI Number  CTRI/2025/02/080485 [Registered on: 13/02/2025] Trial Registered Prospectively
Last Modified On: 09/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Clinical Study to Check the Efficacy and Safety of Arshtab-h70 in the Management of Primary Hemorrhoids 
Scientific Title of Study   An Open-label, Single-arm Clinical Study to Evaluate the Efficacy and Safety of Arshtab-h70 in the Management of Primary Hemorrhoids 
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 Amit A Paliwal 
Designation  MS PhD Shalyatantra 
Affiliation  Dr D Y Patil College of Ayurved and Research Centre Pimpri Pune 
Address  OPD and IPD of Shalyatantra of Dr D Y Patil College of Ayurved and Research Centre Sant Tukaram Nagar Pimpri Pune

Pune
MAHARASHTRA
411018
India 
Phone  8087975264  
Fax    
Email  dramitpaliwal@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Bhagyashri A Chakole 
Designation  MD Samhita Siddhanta and Sanskrit 
Affiliation  Dr D Y Patil College of Ayurved and Research Centre Pimpri Pune 
Address  Dr D Y Patil College of Ayurved and Research Centre Sant Tukaram Nagar Pimpri Pune

Pune
MAHARASHTRA
411018
India 
Phone  90965 87493  
Fax    
Email  bhagyashri.chakole@dpu.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Amit A Paliwal 
Designation  MS PhD Shalyatantra 
Affiliation  Dr D Y Patil College of Ayurved and Research Centre Pimpri Pune 
Address  Dr D Y Patil College of Ayurved and Research Centre Sant Tukaram Nagar Pimpri Pune

Pune
MAHARASHTRA
411018
India 
Phone  8087975264  
Fax    
Email  dramitpaliwal@gmail.com  
 
Source of Monetary or Material Support  
Sudhatatva Pharmacy Pimpri, Pune – 18, Maharashtra, India 
 
Primary Sponsor  
Name  Sudhatatva Pharmacy  
Address  Sudhatatva Pharmacy Pimpri, Pune – 411018, Maharashtra, India 
Type of Sponsor  Other [self] 
 
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 Amit A Paliwal  Dr D Y Patil College of Ayurved and Research Centre Pimpri Pune  OPD and IPD of Shalyatantra of Dr D Y Patil College of Ayurved and Research Centre Sant Tukaram Nagar Pimpri Pune
Pune
MAHARASHTRA 		 8087975264

dramitpaliwal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Dr DYPCA and RC Institutional Ethics Committee Pimpri Pune  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K649||Unspecified hemorrhoids. Ayurveda Condition: ARSAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: ARSHTAB-H70, Reference: Sushruta samhita, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 700(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: lukewarm water), Additional Information: The patient will be advised to take ARSHTAB- H70 2 tablets twice daily before meals with lukewarm water. For 15 days.
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1 Symptomatic primary hemorrhoids, Grades I-II by direct anoscopic visualization (anoscopic visualization not required if Grade determined by colonoscopy within 21 days prior to Day 1).
2 Bleeding from hemorrhoids for two consecutive days prior to randomization (Day 1).
3 The patient having Bleeding hemorrhoids, Pain in anal region due to piles complication (i.e. Inflammation, thrombosis), prolaps, itching, constipation two days prior to randomization (Day 1) will be selected for this clinical study.
4 For female patients cause of bleeding due to menses should be ruled out.
5 Able to attempt bowel movements daily (defined as trying to have a bowel movement while sitting on the toilet for at least a few minutes, at least once daily)
6 Able to communicate adequately with the investigator and to comply with the requirements for the entire study.
7 Capable of and freely willing to provide written informed consent prior to participating in the study.
8 Signed informed consent prior to any study-mandated procedure.
9 Willing to comply with daily protocol.
 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Reduction in symptoms scores at endpoint as compared to baseline values in symptoms of Bleeding per rectum, Size of pile mass.  Follow-up visits will be scheduled on the 7th, 15th, and 21st days after enrollment. A window period of ± 2 days will be allowed for each follow-up visit. 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in symptoms scores at endpoint as compared to baseline values in symptoms of Protrusion of mass, Constipation, Tenderness, Pain.  Follow up visits will be scheduled at 7th, 15th, & 21st days after enrollment. A window period of ± 2 days will be allowed for each follow up visit. 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
Final Enrollment numbers achieved (Total)= "24"
Final Enrollment numbers achieved (India)="24" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   24/02/2025 
Date of Study Completion (India) 20/10/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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
Modification(s)  

This is a single-Arm, prospective study involving patients with primary hemorrhoids. Adult male and female participants, aged 18 to 75 years, diagnosed with primary hemorrhoids, will be selected for the study. Eligible participants, based on inclusion and exclusion criteria, will provide written informed consent during the screening visit. during which laboratory reports will be reviewed to confirm eligibility. Following this assessment, patients who meet all criteria will be randomly assigned to study group consisting of patients with primary hemorrhoids without secondary complications, the patient physical examination, DRE, and basic blood investigation like CBC and RBS will be performed.  

The safety of the treatment will be assessed by monitoring adverse events, conducting routine hematological and biochemical tests, performing physical exams, and recording vital signs. 
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