| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K642||Third degree hemorrhoids. Ayurveda Condition: ARSAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other 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: | | 2 | Comparator Arm (Non Ayurveda) | | - | Tab Diclofenac Sodium | Dosage 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. |