| CTRI Number |
CTRI/2025/08/093057 [Registered on: 14/08/2025] Trial Registered Prospectively |
| Last Modified On: |
13/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study Comparing the Effectiveness of Bilwa Majja Choorna and Nagkeshar Choorna in Treating Raktarsha (Bleeding Piles) |
|
Scientific Title of Study
|
Randomised controlled clinical trial to compare the efficacy of Bilwa Magaja Choorna with Nagakeshar Choorna in the management of Raktarsha |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shrikant Balaji Bhosale |
| Designation |
Pg scholar |
| Affiliation |
Tilak Ayurved Mahavidyalaya and Seth Tarachand Ramnath Charitable Ayurvedic Hospital |
| Address |
Tilak Ayurved Mahavidyalaya, Department of Shalyatantra,2nd floor, 583/2, Rasta Peth, Pune
Pune
MAHARASHTRA
411011
India |
| Phone |
8208429145 |
| Fax |
|
| Email |
shrikantbhosale0024@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dhanraj Gaikwad |
| Designation |
Associate professor department of Shalyatantra |
| Affiliation |
Tilak Ayurved Mahavidyalaya and Seth Tarachand Ramnath Charitable Ayurvedic Hospital |
| Address |
Tilak Ayurved Mahavidyalaya, Department of Shalyatantra,2nd floor, 583/2, Rasta Peth, Pune
Pune
MAHARASHTRA
411011
India |
| Phone |
9422342048 |
| Fax |
|
| Email |
draj.gaikwad@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shrikant Balaji Bhosale |
| Designation |
Pg scholar |
| Affiliation |
Tilak Ayurved Mahavidyalaya and Seth Tarachand Ramnath Charitable Ayurvedic Hospital |
| Address |
Tilak Ayurved Mahavidyalaya, Department of Shalyatantra,2nd floor, 583/2, Rasta Peth, Pune
Pune
MAHARASHTRA
411011
India |
| Phone |
8208429145 |
| Fax |
|
| Email |
shrikantbhosale0024@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tilak Ayurved Mahavidyalaya and Seth Tarachand Ramnath Charitable Ayurvedic Hospital, Rasta Peth, Pune 411011, Maharashtra India |
|
|
Primary Sponsor
|
| Name |
Tilak Ayurved Mahavidyalaya Pune |
| Address |
Tilak Ayurved Mahavidyalaya, Rasta Peth, Pune 411011 |
| 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 |
| Dr Shrikant Balaji Bhosale |
Seth Tarachand Ramnath Charitable Ayurvedic Hospital Pune |
OPD no 7 department of Shalyatantra Pune
Pune
MAHARASHTRA |
8208429145
shrikantbhosale0024@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical committee Tilak Ayurved Mahavidyalaya, Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K649||Unspecified hemorrhoids. Ayurveda Condition: ARSAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Bilwa magaja choorna, Reference: Chikitsarnav purvardh arshoadhikar 96, Route: Oral, Dosage Form: Churna/ Powder, Dose: 12(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: Koshnajala), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Nagkeshar Choorna , Reference: Charak samhita , Route: Oral, Dosage Form: Churna/ Powder, Dose: 12(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: Navneet and sharkara ), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients having Raktarsha (1st degree,2nd degree) will be selected.
2.Patient with Hb less than 8gm%
3.Patient of age between 18-60 years will be taken.
4.Selected of patient will be done irrespective of sex, socioeconomic class, religion |
|
| ExclusionCriteria |
| Details |
1.Known case of 3rd and 4th degree haemorrhoids
3rd Degree haemorrhoids- Piles prolapsed during defecation, can be replaced back only by manual help.
4th Degree haemorrhoids- piles that are permanently prolapsed
2. Patients with Hb more than 8 gm%
3. Pregnancy
4. Known case of HIV, HBsAg excluded. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
The use of Bilwa Magaja Choorna with Nagkeshar Choorna was effective in reducing Rakta Strava in Raktaarsha.
|
1st follow up on 7th day and then on 14th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Adverse drug reaction observed during treatment of Raktarsha with Bilwa magaja choorna |
1st follow up on 7th day and then on 14th day |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
25/08/2025 |
| 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
|
Objective To evaluate and compare the clinical efficacy of Bilwa Magaja Choorna and Nagkeshar Choorna in treating Raktarsha (bleeding haemorrhoids), and to assess potential adverse effects
Background
Raktarsha, a form of Arsha (haemorrhoids), is a common anorectal disorder in Ayurveda, linked to poor diet, sedentary lifestyle, and Agnimandya (impaired digestion).
Modern surgical treatments often have complications; hence, the study seeks safer, cost-effective, Ayurvedic alternatives.
Hypothesis
Null Hypothesis Bilwa Magaja Choorna is as effective as Nagkeshar Choorna.
Alternative Hypothesis Bilwa Magaja Choorna is more effective.
Methodology
Design: Open-label, randomized controlled clinical trial.
Participants: 70 patients (35 in each group) with 1st and 2nd degree Raktarsha.
Intervention
Group A (Trial): Bilwa Magaja Choorna (12 gm) with warm water.
Group B (Control): Nagkeshar Choorna (12 gm) with Navneet and Khadisakhar.
Duration: 14 days with follow-ups on Day 7 and Day 14.
Common Supportive Drug: Gandharva Haritaki Choorna (laxative).
Assessment Parameters
Subjective: Quantity of bleeding per anus.
Objective: Frequency of bleeding.
Investigations: Hb%, HIV, HBsAg.
Inclusion Criteria:
Age 18–60 years, 1st/2nd degree Raktarsha, Hb less than 8 gm%.
Exclusion Criteria
3rd/4th degree haemorrhoids, Hb <8 gm%, pregnancy, HIV/HBsAg positive.
Analysis Tools:
Statistical Tests: Wilcoxon signed-rank test (subjective), t-test (objective).
Knowledge Gap & Rationale:
No prior comparative study on Bilwa Magaja Choorna alone.
Expected to be cost-effective, safe, and easy to administer.
Conclusion:
The study aims to establish Bilwa Magaja Choorna as a potentially more effective Ayurvedic treatment for Raktarsha compared to the standard Nagkeshar Choorna. |