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CTRI Number  CTRI/2025/04/084845 [Registered on: 15/04/2025] Trial Registered Prospectively
Last Modified On: 15/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Efficacy of Shulaghna Saptak Vati in post operative pain management 
Scientific Title of Study   Clinical Efficacy of Shulaghna Saptak Vati in post operative pain management after open Haemorrhoidectomy- A Randomized Controlled Clinical Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  AMRUTHA SURESH 
Designation  PG SCHOLAR 
Affiliation  Institute of Teaching and Research in Ayurveda 
Address  Department of Shalya Tantra Institute of Teaching and Research in Ayurveda Jamnagar

Jamnagar
GUJARAT
361008
India 
Phone  9745362889  
Fax    
Email  amruthasheeja3@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Prof Dr T S DUDHAMAL 
Designation  H.O.D 
Affiliation  Institute of Teaching and Research in Ayurveda, Jamnagar 
Address  Department of Shalya Tantra Institute of Teaching and Research in Ayurveda Jamnagar

Jamnagar
GUJARAT
361008
India 
Phone  9745362889  
Fax    
Email  drtsdudhamal@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Prof Dr T S DUDHAMAL 
Designation  H.O.D 
Affiliation  Institute of Teaching and Research in Ayurveda, Jamnagar 
Address  Department of Shalya Tantra Institute of Teaching and Research in Ayurveda Jamnagar

Jamnagar
GUJARAT
361008
India 
Phone  9745362889  
Fax    
Email  drtsdudhamal@gmail.com  
 
Source of Monetary or Material Support  
Institute of Teaching and Research in Ayurveda Jamnagar 
 
Primary Sponsor  
Name  Institute of Teaching and Research in Ayurveda, Jamnagar 
Address  Institute of Teaching and Research in Ayurveda , Jamnagar 361008 
Type of Sponsor  Research institution and hospital 
 
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 
AMRUTHA SURESH  Institute of Teaching and Research in Ayurveda Jamnagar  Shalya Tantra IPD Institute of Teaching and Research in Ayurveda Jamnagar
Jamnagar
GUJARAT 
9745362889

amruthasheeja3@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee Institute of Teaching and Research in Ayurveda Jamnagar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K642||Third degree hemorrhoids. Ayurveda Condition: ARSAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: Shulaghna Saptak Vati, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: WATER), Additional Information:
2Comparator Arm (Non Ayurveda)-Tab Diclofenac SodiumDosage 50 mg Two times in a day for 7 days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Post-open patient of Open haemorrhoidectomy with complaints of pain between the age group 18-60 years 
 
ExclusionCriteria 
Details  1. Age less than 18 years and more than 60 years.
2. Patients who underwent operation for hemorrhoid associated with fissure or fistula-in-ano, who is having complications like bleeding from the operated site and surgical site infection IBS OR diagnosed cases Crohn’s disease, in immunocompromised states like HIV, HbsAg, VDRL, HCV
3. Known cases of Malignancy, Tuberculosis.
4. Uncontrolled Hypertension (diastolic BP greater than 90mmHg, Systolic BP greater than 160mmHg), uncontrolled Diabetes Mellitus (FBS greater than 110mg/dl, PPBS greater than 140mg/dl), Cardiac disorders.
5. Pregnant and lactating woman.
 
 
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 
Relief in the post operative pain of open haemorrhoidectomy patients  1st day and 7th day 
 
Secondary Outcome  
Outcome  TimePoints 
Absence of recurrence of pain in the folllow up period  22nd day 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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 
Date of First Enrollment (India)   16/06/2025 
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="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  

Arsha is one among the eight grave diseases mentioned in Susruta Samhita. It can be compared with hemorrhoids in Western system of medicine. At least 50% of people over the age of 50 years have some degree of symptom of hemorrhoid. Open Haemorrhoidectomy (Milligan Morgan) is one among the treatments of choice in 3rd and 4th degree hemorrhoids. However it is associated with significant amount of post operative pain, which may increase the patient sufferings and can lead to post operative adverse events such as urine retention. Diclofenac analgesics are commonly used to treat post operative pain. These conventional analgesics and anti-inflammatory drugs have been known of producing a wide range of adverse effects. Hence there is an urgent need for research into novel analgesics that are both safe and efficacious, with acceptable tolerability and demonstrated efficacy.  Shulaghna Saptaka Vati is a polyherbal formulation which is having proven analgesic and anti-inflammatory in animal models. This formulation contains various chemical constituents such as B-boswellic acid, Glycerrhizine, Flavonoids, Tinosporin, Saponins etc. which can act in both peripheral and central analgesic mechanism. Data regarding the oral acute toxicity studies are also carried out in animals. Till date no human clinical research works on pain management potential of Shulaghna Saptaka Vati are available. Thus, this drug has been selected in comparison with the most commonly used diclofenac analgesics in post operative pain management of open hemorrhoidectomy.40 post operative cases of open hemorrhoidectomy will be selected irrespective of the sex, religion, caste, occupation etc. from IPD of hospital I.T.R.A., Jamnagar. The selected patients will be divided into following two groups by computer generated randomized method (Graph pad).

GROUP-A (Trial group):

        Shulaghna Saptak Vati (500mg) 2 tablets thrice daily with lukewarm water after food for initial 7 post operative days after open Hemorrhoidectomy

In GROUP-B (Controlled group)

·        Tab Diclofenac sodium 50mg one tablet twice daily with water, after food for initial 7 post operative days after open Hemorrhoidectomy.

Observations will be recorded systematically using a structured proforma .Statistical analysis will be done in order to evaluate and compare the effect of of Shulghna Saptak Vati and Tab Diclofenac in post operative pain management after hemorrhoidectomy. Diclofenac analgesics are commonly used to treat post operative pain. These conventional analgesics and anti-inflammatory drugs have been known of producing a wide range of adverse effects. Hence there is an urgent need for research into novel analgesics that are both safe and efficacious, with acceptable tolerability and demonstrated efficacy. 

 
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