| CTRI Number |
CTRI/2026/01/102544 [Registered on: 30/01/2026] Trial Registered Prospectively |
| Last Modified On: |
30/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Clinical Study to know the Effect of Homoeopathic medicine Aesculus Hippocastanum with potency 6C in Non Bleeding External Haemorrhoids in Shift workers performing Rotational Duties in Different time Shifts. |
|
Scientific Title of Study
|
A Clinical Study to Evaluate the Efficacy of Aesculus Hippocastanum 6C in Non Bleeding External Hemorrhoids in Shift Workers. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MUKESHKUMAR GORDHANBHAI PARMAR |
| Designation |
PG SCHOLAR |
| Affiliation |
Parul Institute of Homoeopathy and Research Hospital |
| Address |
Parul Instittue of Homoeopathy and Research Hospital, 3rd Floor, Room No. 402, Dept. of Homoeopathic Materia Medica, At. Ishwarpura, Po. Limda, Ta. Waghodia, Di. Vadodara- 391760
Vadodara
GUJARAT
391760
India |
| Phone |
9925961883 |
| Fax |
|
| Email |
parmarmukesh006@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR MAMTA TAPAS |
| Designation |
Professor and HOD |
| Affiliation |
Parul Institute of Homoeopathy and Research Hospital |
| Address |
Parul Instittue of Homoeopathy and Research Hospital, 3rd Floor, Room No. 402, Dept. of Homoeopathic Materia Medica, At. Ishwarpura, Po. Limda, Ta. Waghodia, Di. Vadodara- 391760
Vadodara
GUJARAT
391760
India |
| Phone |
9604287095 |
| Fax |
|
| Email |
mamta.tapas87086@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
MUKESHKUMAR GORDHANBHAI PARMAR |
| Designation |
PG SCHOLAR |
| Affiliation |
Parul Institute of Homoeopathy and Research Hospital |
| Address |
Parul Instittue of Homoeopathy and Research Hospital, 3rd Floor, Room No. 402, Dept. of Homoeopathic Materia Medica, At. Ishwarpura, Po. Limda, Ta. Waghodia, Di. Vadodara- 391760
Vadodara
GUJARAT
391760
India |
| Phone |
9925961883 |
| Fax |
|
| Email |
parmarmukesh006@gmail.com |
|
|
Source of Monetary or Material Support
|
| Parul Institute of Homoeopathy and Research, 3rd Floor, Room No. 402, Dept. of Homoeopathic Materia Medica, At. Ishwarpura, Po. Limda, Ta. Waghodia, Di. Vadodara- 391760 |
|
|
Primary Sponsor
|
| Name |
Parul Institute of Homoeopathy and Research |
| Address |
Parul Institute of Homoeopathy and Research, At. Ishwarpura, Po. Limda, Ta. Waghodia, Di. Vadodara - 391760 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| MUKESHKUMAR GORDHANBHAI PARMAR |
Parul Institute of Homoeopathy and Research, At. Ishwarpura, Po. Limda, Ta. Waghodia, Di. Vadodara - 391760 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR MUKESHKUMAR GORDHANBHAI PARMAR |
Parul Institute of Homoeopathy and Research Hospital |
Parul Institute of Homoeopathy and Research, 3rd Floor, Room No. 402, Dept of Homoeopathic Materia Medica At. Ishwarpura, Po. Limda, Ta. Waghodia, Di. Vadodara - 391760
Vadodara
GUJARAT |
9925961883
parmarmukesh006@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE FOR HUMAN RESEARCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K649||Unspecified hemorrhoids, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Aesculus Hippocastanum 6C Potency |
Aesculus Hippocastanum Single Homoeopathic Medicine In 6C Potency Will Be Given In 4 Globuls Form 3 Times In A Day Orally To The Workers Who Work In Different Shifts Of Time And Having Symptoms Such As Pain, Swelling And Itching In Anal Region With Difficulty In Sitting And Burning Sensation After Passing The Stool Which Is Similiar To The Non Bleeding External Hemorrhoids. The Follow Up Will Done Weekly For 2 Months. |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients suffering from non bleeding external haemorrhoids
2. Shift workers performing duties in rottation and night shifts
3. Willing to participate and give informed consent
4. Symptoms Consistent with Aesculus Hippocastanum indications |
|
| ExclusionCriteria |
| Details |
1. Patient having bleeding piles, prolapse haemorrhoids or internal haemorrhoids
2. Individuals with systemic illness like Diabetes, Hypertension, Tuberculosis or malignancy
3. Pregnant or lactating women Patient under concurrewnt treatment with allopathy or ayurvedic medication for haemorrhoids
4. Patient with history of surgical intervention for haemorrhoids |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Observe the Changes in Symptom Score before and after treatment with Aesculus Hippocastanum 6C |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To reduce pain, dryness and itching in non bleeding external haemorrhoids in shift workers |
3 months |
|
|
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
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
02/03/2026 |
| 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="11"
Days="30" |
|
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
|
This study aims to find out whether a homeopathic medicine called Aesculus Hippocastanum 6C can help reduce pain, swelling, itching, and discomfort in people suffering from non-bleeding external piles, especially those who work in night shifts or rotating shifts. Shift work often disturbs sleep, eating habits, and bowel routine, which can worsen piles. In this hospital-based clinical study conducted at Parul Institute of Homoeopathy and Research Hospital, Vadodara, 30 patients will be given the same homeopathic medicine and followed for about three months. Their symptoms will be recorded before starting treatment and during regular follow-ups to see how much improvement occurs. In simple terms, the study checks whether this homeopathic treatment is safe and effective in relieving non-bleeding piles in shift workers. |