| CTRI Number |
CTRI/2025/03/082398 [Registered on: 17/03/2025] Trial Registered Prospectively |
| Last Modified On: |
14/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect Of Ayurvedic Medicine In Piles. |
|
Scientific Title of Study
|
Randomized Controlled Trial To Study The Efficacy of Patrakadi Vati In The Management of Abhyantar Arsha With Special Reference To First And Second Degree Internal Haemorrhoids. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gaurav Umesh Sachdev |
| Designation |
PG Scholar |
| Affiliation |
Siddhakala Ayurved mahavidyalay, Sangamner |
| Address |
OPD number 6, Shalyatantra Department, Siddhakala Ayurved Mahavidyalaya, Pimparne road, Sangamner, Ahmadnagar, Maharashtra, 422605
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
8552024074 |
| Fax |
|
| Email |
drgauravsachdev7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Naimish Kishor Saraf |
| Designation |
Head of Department of Shalyatantra |
| Affiliation |
Siddhakala Ayurved mahavidyalay, Sangamner |
| Address |
Shalyatantra Department, Siddhakala Ayurved Mahavidyalaya, Pimparne road, Sangamner, Ahmadnagar, Maharashtra, 422605
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
9766786123 |
| Fax |
|
| Email |
naimishsaraf@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Naimish Kishor Saraf |
| Designation |
Head of Department of Shalyatantra |
| Affiliation |
Siddhakala Ayurved mahavidyalay, Sangamner |
| Address |
Shalyatantra Department, Siddhakala Ayurved Mahavidyalaya, Pimparne road, Sangamner, Ahmadnagar, Maharashtra, 422605
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
9766786123 |
| Fax |
|
| Email |
naimishsaraf@gmail.com |
|
|
Source of Monetary or Material Support
|
| Siddhakala Ayurved Mahavidyalaya, Pimparne road , Sangamner khurd, Sangamner ,
Ahilyanagar , Maharashtra , India. Pincode- 422605. |
|
|
Primary Sponsor
|
| Name |
Gaurav Umesh Sachdev |
| Address |
Siddhakala Ayurved Mahavidyalaya, Pimparne road , Sangamner khurd, Sangamner ,
Ahilyanagar , Maharashtra , India. Pincode- 422605. |
| Type of Sponsor |
Other [Self] |
|
|
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 Gaurav Umesh Sachdev |
Siddhakala Ayurved Mahavidyalay,Sangamner |
OPD number 6, Shalyatantra Department, Siddhakala Ayurved Mahavidyalaya, Pimparne road, Sangamner, Ahmadnagar, Maharashtra, 422605
Ahmadnagar
MAHARASHTRA |
8552024074
drgauravsachdev7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Board of Ayurved Research and Statistics Committee of Siddhakala Ayurved Mahavidyalaya, Sangamner |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K641||Second degree hemorrhoids. Ayurveda Condition: ARSAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Patrakadi Vati, Reference: Harit Samhita, Trutiya Sthan (Chikitsa Sthan), Chapter No.11, Shlok No. 32, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: Gudodaka), Additional Information: Aushadh Sevan Kala- Vyaanudaan Kala | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Arshoghani Vati, Reference: Siddha Yoga Sangraha, Chapter No. 9, Pg No. 61, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 300(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: -Jal), Additional Information: -Aushadh Sevan Kala- Vyaanudaan Kala |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients of age group 18 to 50 years.
2.Patients of both genders are accepted.
3.Patients diagnosed with Abhayantar Arsha [First and Second degree Haemorrhoids) will be selected.
4.Patients who provide written consent.
5.Individuals experiencing Haemorrhoidal symptom (pain, bleeding prolapse) for atleast 4 weeks. |
|
| ExclusionCriteria |
| Details |
1.Patient with Haemoglobin less than 8gm%.
2.With known case of 3rd an 4th degree hemorrhoids,fissure,fistula,prolapsed rectum.
3.Patient with severe systemic illness such as HTN,Uncontrolled DM,CVD and HIV and Immunocompromised patients.
4.Pregnant And lactating mother.
5. Patients with active gastrointestinal disease Such as UC,CD,CA.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
The primary outcome of this study is to assess the efficacy of oral administration of 250mg Patrakadi Vati with Gudodak twice daily for 28 days in managing Abhyantar Arsha (First and Second Degree Internal Hemorrhoids) by evaluating:
Reduction in bleeding episodes,
Improvement in constipation,
Decrease in anal pain,
Regression in pile mass size and number. |
0,7th,14th and 28th Day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Duration of symptom relief (pain, constipation, pile mass regression) ,assessed on Day 7, Day 14, & Day 28.
2. Reduction in bleeding episodes measured by frequency & severity of hemorrhoidal bleeding on Day 7, Day 14, & Day 28.
3. Cost-effectiveness analysis comparison of healthcare expenses, treatment duration, & patient recovery time at the end of the study.
4. Objective improvements in hemorrhoidal size & number ,assessed via Proctoscopy on Day 0, Day 7, Day 14, & Day 28. |
Day 0th,7th,14th & 28th |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
01/04/2025 |
| 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="6"
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
|
This study is a randomized open labelled controlled clinical trial comparing the safety and efficacy of Patrakadi Vati 250 mg and controlled Arshoghani Vati 300 mg for 28 days in 80 patients with first and second degree internal haemorrhoids. |