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CTRI Number  CTRI/2025/04/084845 [Registered on: 15/04/2025] Trial Registered Prospectively
Last Modified On: 12/08/2026
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)= "40"
Final Enrollment numbers achieved (India)="40" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   16/06/2025 
Date of Study Completion (India) 15/04/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
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)  

The present randomized controlled clinical trial was undertaken to evaluate the clinical efficacy of Shulaghna Saptak Vati in the management of post-operative pain following open haemorrhoidectomy and to compare its efficacy with Tab. Diclofenac sodium.

Based on the observations, statistical analysis, and clinical outcomes, both Shulaghna Saptak Vati and Tab. Diclofenac sodium were found to be effective in reducing post-operative pain following open haemorrhoidectomy. Within-group analysis demonstrated a statistically highly significant reduction in pain scores in both groups throughout the seven-day treatment period.

Comparative analysis revealed that patients treated with Shulaghna Saptak Vati experienced significantly greater pain relief during the early post-operative period, particularly from the second to the fifth post-operative day. The trial drug also demonstrated significantly lower cumulative pain scores, lower pain area under the curve (AUC), and earlier achievement of a sustained pain-free state when compared with Tab. Diclofenac sodium. Although complete pain relief was achieved in both groups by the seventh post-operative day, recovery was faster and the overall pain burden was significantly lower in patients receiving Shulaghna Saptak Vati. Thus the null hypothesis is rejected and alternate hypothesis is accepted that is Shulaghna saptak Vati is more effective than tab diclofenac sodium in post operative pain management after open heamorrhoidectomy

The favourable outcome observed with Shulaghna Saptak Vati may be attributed to the synergistic actions of its constituent drugs, which possess Vedanahara, Shothahara, Vranaropana, antioxidant, and anti-inflammatory properties. These combined actions not only alleviate post-operative pain but also support the physiological process of wound healing, thereby facilitating early recovery following open haemorrhoidectomy.

Diclofenac sodium, the standard comparator used in the present study, also produced highly significant analgesia through inhibition of cyclooxygenase enzymes and suppression of prostaglandin synthesis. However, its therapeutic effect is primarily limited to symptomatic pain relief, whereas Shulaghna Saptak Vati appears to provide a broader therapeutic effect by reducing inflammation and supporting tissue healing in addition to its analgesic action.

No serious adverse drug reactions or treatment-related complications attributable to Shulaghna Saptak Vati were observed during the study period, indicating that the formulation was safe and well tolerated.

Therefore, within the limitations of the present study, it can be concluded that Shulaghna Saptak Vati is an effective, safe, and clinically superior Ayurvedic formulation for the management of post-operative pain following open haemorrhoidectomy. The formulation provided earlier pain relief, reduced the cumulative pain burden, shortened the time required to achieve a sustained pain-free state, and improved overall post-operative recovery when compared with Tab. Diclofenac sodium.


 
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