| CTRI Number |
CTRI/2024/12/078022 [Registered on: 12/12/2024] Trial Registered Prospectively |
| Last Modified On: |
30/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [LOCAL APPLICATION] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Randomised control trial for Evaluation of comparative Efficacy of Pileave Ointment
versus Pippalyadi Taila in the Management of Grade II Hemorrhoids
|
|
Scientific Title of Study
|
Evaluation of comparative Efficacy of Pileave Ointment
versus Pippalyadi Taila in the Management of Grade II Hemorrhoids- A RCT
|
| 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 Shijo YJ |
| Designation |
Associate Professor |
| Affiliation |
Shri Dhanwantry Ayurvedic college and Hospital chandigarh |
| Address |
Department of Shalyatantra room no.105
First floor
Shri Dhanwantry Ayurvedic college and Hospital
sector 46 B ,chandigarh
Department of shalyatantra room no 5
sector 46 B ,chandigarh
Chandigarh
CHANDIGARH
160047
India |
| Phone |
8547232365 |
| Fax |
|
| Email |
drshijoyj@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shijo YJ |
| Designation |
Associate Professor |
| Affiliation |
Shri Dhanwantry Ayurvedic college and Hospital chandigarh |
| Address |
Department of Shalyatantra room no 5
Shri Dhanwantry Ayurvedic college and Hospital
sector 46 B
Chandigarh
Department of shalyatantra room no 5
sector 46 B ,chandigarh
Chandigarh
CHANDIGARH
160047
India |
| Phone |
8547232365 |
| Fax |
|
| Email |
drshijoyj@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aditi |
| Designation |
Assistant Professor |
| Affiliation |
Shri Dhanwantry Ayurvedic college and Hospital chandigarh |
| Address |
Department of shalyatantra room no 5
Shri Dhanwantry Ayurvedic college and Hospital
Sector 46 B
Chandigarh
Department of shalyatantra room no 5
Shri Dhanwantry Ayurvedic college and Hospital sector 46 B chandigarh
Chandigarh
CHANDIGARH
160047
India |
| Phone |
9511213070 |
| Fax |
|
| Email |
aditi.sharma019@gmail.com |
|
|
Source of Monetary or Material Support
|
| Emami Limited
13 B T Road
Belghoria
Kolkata
WestBengal
-700056 |
|
|
Primary Sponsor
|
| Name |
Emami Limited |
| Address |
Emami limited, 13 BT Road, Belghoria, Kolkata-700056 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Shijo YJ |
Shri Dhanwantry Ayurvedic college and Hospital |
Department of shalyatantra room no 5
first floor
Shri Dhanwantry ayurvedic college
Sector 46 B
Chandigarh
Chandigarh
CHANDIGARH |
8547232365
drshijoyj@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Shri dhanwantry ayurvedic college& Hospital |
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 | Other than Classical | | (1) Medicine Name: Pileave ointment, Reference: NA, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 2(mg), Frequency: bd, Bhaishajya Kal: Muhurmuhu, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: Zandu Pileave ointment- After washing anal area with luke warm water, take 1 gm of Zandu Pileave ointment on finger and apply properly on affected area. Repeat the procedure 2 times a day morning and bed time. | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Pippalyadi Anuvasana Taila , Reference: Bhaishajyaratnavali Arshorogadhikara 115-118, Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: bd, Bhaishajya Kal: Muhurmuhu, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: Pippalyadi Anuvasana Taila Pichu After washing anal area with luke warm water 5 ml oil taken in cotton and is kept in the affected area. |
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients suffering from below mentioned minimum three symptoms of piles:
1. Swelling
2. Tenderness
3. Bleeding (Hb more than 10gm)
4. Perianal Pain
5. Burning
6. Itching/ irritation
|
|
| ExclusionCriteria |
| Details |
1. Patients suffering from 3rd degree heamorrhoids
2. Patients who develop secondary complication of Colitis, intestinal obstruction etc
3. Any other serious illness e.g. Hepatic or renal failure/Severe Anaemia
4. Known hypersensitivity or allergy to one or more of the herbal ingredients
5. Other debilitating neurological or psychiatric disorders
6. Any condition likely to hinder the compliance with the protocol.
7. Severe infective / other organic illness.
8. Any concomitant serious disorder of organs.
9. Any other drug treatment being received simultaneously on long-term basis.
|
|
|
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 |
Reduction of symptoms of Haemorrhoids:
1. Swelling
2. Tenderness
3. Bleeding (Hb more than 10gm)
4. Perianal Pain
5. Burning
6. Itching/ irritation
assessment of Hemorrhoidal Disease Symptom Score
Assessment of Anorectal Symptom Severity and Quality of Life Questionnaire (ARSSQoL)
|
Patients will be assessed 5 times –
Baseline
7th day
15th day
21st day
30th day (with medication)
45th day (without medication for follow up)
Expecting significant clinical improvement with reduced clinical signs and symptoms in Haemorrhoids as compared to Standard of care . |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Assessment of Anorectal Symptom Severity & Quality of Life Questionnaire ARSSQoL
Improvement In quality of life of heamorrhoid patients |
45th day without medication for follow up
Expecting significant clinical improvement with reduced clinical signs & symptoms in Haemorrhoids as compared to Standard of care . |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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
|
N/A |
|
Date of First Enrollment (India)
|
23/12/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
23/12/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) - Proposals should be directed to email ID - drshijoyj@gmail.com to gain access
- For how long will this data be available start date provided 28-11-2024 and end date provided 10-10-2029?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
•Arsha (Haemorrhoids) are swollen blood vessels of the rectum. Anyone at any age can be affected by haemorrhoids. It is very common, with about 50% of people experiencing them at some time in their life. •Ayurveda the ancient science of life, has described it as anorectal disorders in very detailed manner.
•“arivat pranan shrunati hinati itiarshaha†•Zandu Pileave Ointment (ZPO) is a well-known Ayurvedic product being marketed in India to overcome the symptoms associated with dry and bleeding piles. •The major ingredients are Jatyadi Taila, Nimba taila, Apamarga, Khshara, Yashadbhasma, Tankana Bhasma, amala along with other Ayurvedic ingredients, which are well known
to have analgesic, anti-inflammatory, wound healing and antimicrobial properties. Need of study To validate the clinical efficacy of ZanduPileave Ointment on the basis of scientific parameters in the patients suffering from Arsha. To evaluate the safety of Zandu PileaveOintment in the patients suffering from Arsha. To compare the efficacy of Pileave ointment with the standard of care• To evaluate the safety of Zandu PileaveOintment in the patients suffering from Arsha. To compare the efficacy of Pileave ointment with the standard of care
Hypothesis The drug for proposed study (Zandu PileaveOintment) will be more effective in the management of Arsha (Piles) as compared to Pippalyadi tail. |