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CTRI Number  CTRI/2025/12/098505 [Registered on: 05/12/2025] Trial Registered Prospectively
Last Modified On: 04/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   A Single Arm Clinical Study to evaluate the efficacy of Shigrumooladi lepa in the management of raktarsha with special reference to 1st and 2nd degree hemorrhoids. 
Scientific Title of Study   A Single Arm Clinical Study to evaluate the efficacy of Shigrumooladi lepa in the management of raktarsha with special reference to 1st and 2nd degree 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 Vijender Kumar 
Designation  Shalya Tantra Post Graduate Scholar 
Affiliation  Jeevan Jyoti Ayurvedic Medical College and Hospital,Aligarh 
Address  Department of PG Studies in Shalya Tantra,Jeevan Jyoti Ayurvedic Medical College and Hospital, 10th K.m Mile Stone,Khair Road ,Lodha,Aligarh

Aligarh
UTTAR PRADESH
202140
India 
Phone  6360729887  
Fax    
Email  kumarvijender985@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Yati Tiwari  
Designation  Professor in Department of Shalya Tantra 
Affiliation  Jeevan Jyoti Ayurvedic Medical College and Hospital,Aligarh 
Address  Department of PG Studies in Shalya Tantra,Jeevan Jyoti Ayurvedic Medical College and Hospital, 10th K.m Mile Stone,Khair Road ,Lodha,Aligarh

Aligarh
UTTAR PRADESH
202140
India 
Phone  8445733813  
Fax    
Email  Yati_tiwari@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Yati Tiwari  
Designation  Professor in Department of Shalya Tantra 
Affiliation  Jeevan Jyoti Ayurvedic Medical College and Hospital,Aligarh 
Address  Department of PG Studies in Shalya Tantra,Jeevan Jyoti Ayurvedic Medical College and Hospital, 10th K.m Mile Stone,Khair Road ,Lodha,Aligarh

Aligarh
UTTAR PRADESH
202140
India 
Phone  8445733813  
Fax    
Email  Yati_tiwari@yahoo.com  
 
Source of Monetary or Material Support  
Department of PG Studies in Shalya Tantra,Jeevan Jyoti Ayurvedic Medical College and Hospital, 10th K.m Mile Stone,Khair Road ,Lodha,Aligarh-202140 
 
Primary Sponsor  
Name  Jeevan Jyoti Ayurvedic Medical College and Hospital 
Address  Jeevan Jyoti Ayurvedic Medical College and Hospital, 10th K.m Mile Stone,Khair Road ,Lodha,Aligarh-202140 
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 Vijender Kumar  Jeevan Jyoti Ayurvedic Medical College and Hospital,Aligarh  Department of PG Studies in Shalya Tantra,Jeevan Jyoti Ayurvedic Medical College and Hospital, 10th K.m Mile Stone,Khair Road ,Lodha,Aligarh-202140
Aligarh
UTTAR PRADESH 
06360729887

kumarvijender985@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Commitee  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: RAKTAJA-ARSAH, (2) ICD-10 Condition:K640||First degree hemorrhoids. Ayurveda Condition: RAKTAJA-ARSAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: SHIGRUMOOLADI LEPA, Reference: Acharya vagbhata in rasaratnasamuchaya raktarsha chikitsa chapter-15,page no. 356 ,shloka -88 , Route: Rectal, Dosage Form: Lepa Churna, Dose: 2(ml), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 28 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  DIAGNOSED PATIENTS OF RAKTASRAVA-ANAL BLEED
PATIENTS OF EITHER SEX
PATIENTS WITH CONTROLLED HYPERTENSION AND DIABETES MELLITUS
FRESH OR PREVIOUSLY OPERATED
PAINFULL OR PAINLESS 
 
ExclusionCriteria 
Details  Patients suffering from Bleeding disorders like-Anal polyp ,prolapsed rectum ,Ulcerative colitis ,Crohn’s Disease ,Carcinoma of rectum and anus .
Infectious diseases like HIV ,HbsAg ,HCV
Pregnant and lactating women
Incontinence of stool
Bleeding diathesis 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Reduction in per-rectal bleeding (Raktasrava).
 
4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in quality of life (QoL) Reduction in associated symptoms such as constipation, pruritus ano,etc  4 weeks 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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   N/A 
Date of First Enrollment (India)   15/12/2025 
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="0"
Months="1"
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  
Arsha, described in Ayurvedic classics as Mamsankura formation in the Gudamarga causing obstruction and producing pain like an enemy, closely resembles hemorrhoids. Hemorrhoids are characterized by dilatation of the hemorrhoidal venous plexus and displacement of the anal cushions, presenting with bleeding, swelling, discomfort, and constipation. They are among the most prevalent anorectal disorders, affecting nearly half of the population by the age of 50, and pose a significant global health burden. Conventional management includes rubber band ligation, sclerotherapy, and infrared coagulation, particularly for Grade I–II hemorrhoids; however, these procedures may cause recurrence or complications.
Ayurveda considers Arsha as a Tridoshaja Vyadhi, with both Shushka and Sravi varieties described based on clinical presentation. Classical texts highlight several formulations possessing Arshoghna properties. Shigrumooladi Lepa, containing Shigrumoola Twak, Arka Patra, and Aja Mutra, demonstrates Katu, Tikta, and Kashaya Rasa contributing to Kaphashamana and Raktastambhana. Its Ushna Veerya and Katu Vipaka facilitate Amapachana, Agnideepana, and reduction of local congestion.
Considering the need for safe, cost-effective, and non-invasive treatment options, the present study aims to evaluate the clinical efficacy of Shigrumooladi Lepa in the management of 1st and 2nd degree hemorrhoids. This research intends to provide scientific evidence supporting its therapeutic benefits and contribute to integrative anorectal care.
 
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