| CTRI Number |
CTRI/2026/03/106138 [Registered on: 13/03/2026] Trial Registered Prospectively |
| Last Modified On: |
13/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Rala–Sarshapa Dhoopana in the Management of Bleeding Hemorrhoids – A Controlled Clinical Study |
|
Scientific Title of Study
|
A CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFECT OF
RALA SARSHAPA DHOOPANA IN THE MANAGEMENT OF RAKTARSH W.S.R. TO BLEEDING 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 |
Dr Swarnima Nilesh Kucheriya |
| Designation |
PG SCHOLAR |
| Affiliation |
DR G D POL FOUNDATION, YMT Ayurvedic Medical College And Hospital |
| Address |
DR G D POL FOUNDATION YMT Ayurvedic Medical College And Hospital ,3rd Floor ,Shalya Tantra Department . Sector-4, Kharghar ,Navi Mumbai 410210
DR G D POL FOUNDATION YMT Ayurvedic Medical College And Hospital ,3rd Floor ,Shalya Tantra Department . Sector-4, Kharghar ,Navi Mumbai 410210
Raigarh
MAHARASHTRA
410210
India |
| Phone |
09422468178 |
| Fax |
|
| Email |
swarajain111@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Varsha Tangade |
| Designation |
Assistant Professor |
| Affiliation |
DR G D POL FOUNDATION, YMT Ayurvedic Medical College And Hospital |
| Address |
DR G D POL FOUNDATION YMT Ayurvedic Medical College And Hospital ,3rd Floor ,Shalya Tantra Department . Sector-4, Kharghar ,Navi Mumbai 410210
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9920798297 |
| Fax |
|
| Email |
vtangde@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Swarnima Nilesh Kucheriya |
| Designation |
PG Scholar |
| Affiliation |
DR G D POL FOUNDATION, YMT Ayurvedic Medical College And Hospital |
| Address |
DR G D POL FOUNDATION YMT Ayurvedic Medical College And Hospital ,3rd Floor ,Shalya Tantra Department . Sector-4, Kharghar ,Navi Mumbai 410210
Raigarh
MAHARASHTRA
410210
India |
| Phone |
09422468178 |
| Fax |
|
| Email |
swarajain111@gmail.com |
|
|
Source of Monetary or Material Support
|
| DR G D POL FOUNDATION,YMT Ayurvedic Medical College And Hospital,3rd Floor,shalya
Department,Sector 4, Navi Mumbai |
|
|
Primary Sponsor
|
| Name |
Dr Swarnima Nilesh Kucheriya |
| Address |
DR G D POL FOUNDATION, YMT Ayurvedic Medical College And
Hospital, 3rd Floor, Shalya Department, Sector 4, Kharghar, Navi
Mumbai 410210 |
| 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 Swarnima Nilesh Kucheriya |
DR G D POL FOUNDATION, YMT Ayurvedic Medical College And Hospital |
DR G D POL FOUNDATION YMT Ayurvedic Medical College And Hospital ,3rd Floor ,Shalya Tantra Department . Sector-4, Kharghar ,Navi Mumbai 410210
Raigarh
MAHARASHTRA |
09422468178
swarajain111@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Dr G D pol foundation YMT ayurvedic medical college and charitable hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K929||Disease of digestive system, unspecified. Ayurveda Condition: RAKTAJA-ARSAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Rala Churna Sarshapa Taila, Reference: (भै. र.9/154 ), Route: Rectal, Dosage Form: Kalka/ Paste , Dose: 10(g), Frequency: od, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 7 Days, Reference: No, Route: -, Dosage Form: Kalka/ Paste , Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: | | 2 | Comparator Arm (Non Ayurveda) | | - | Calcium Dobesilate with Hydrocortisone Ointment | Calcium dobesilate with Hydrocortisone ointment
Locally for 7 days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed cases of bleeding Internal hemorrhoids.(2nd and 3rd Degree)
Age 20–60 years of either sex
Patients with Hb more than 10mg/dl in male and more than 8mg/dl in females
Patients willing to consent and comply
Fit for local Dhoopana procedure |
|
| ExclusionCriteria |
| Details |
Non-bleeding or thrombosed haemorrhoids.
Other associated conditions like Fistula, fissure, carcinoma
Severe anaemia
Pregnant/lactating women.
Malignancies or bleeding due to systemic causes
Chronic bleeding disorders.
Uncontrolled diabetes or hypertension
Known allergy to ingredients (Rala or Sarshapa Taila)
Known patients with Asthma or COPD |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the effect of Rala Sarshapa Dhoopana in reducing per rectal bleeding in patients with bleeding haemorrhoids |
0th day, 4th day, 7th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.
To assess the effect of Rala Sarshapa Dhoopana in associated symptoms like pain and inflammation.
2.
To observe time taken for cessation of bleeding in both intervention groups. |
0th day, 4th day, 7th day |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
31/03/2026 |
| 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="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
|
The Present Study is a PG Thesis Topic By PG Scholar - DR SWARNIMA NILESH KUCHERIYA and Guide Name - DR VARSHA TANGADE Title - A CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFECT OF RALA SARSHAPA DHOOPANA IN THE MANAGEMENT OF RAKTARSH W.S.R. TO BLEEDING HAEMORRHOIDS. According to inclusion and exclusion criteria Group A 33 patients and Group B 33 patients will be selected Group A ( intervention ) will be given Rala Churna sarshapa taila dhoopana locally 10 minutes daily for 7 days Group B ( control/ comparative ) will be given -calcium dobesilate with hydrocortisone ointment local application Once a day for 7 days Total Duration of study is 1 year 6 months. |