| 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
|
|
|
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
|
|
|
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
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (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: - |
|
|
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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. |