| CTRI Number |
CTRI/2025/01/079516 [Registered on: 27/01/2025] Trial Registered Prospectively |
| Last Modified On: |
25/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
Zandu Abhayarishta in the management of Arsha (Hemorrhoids) |
|
Scientific Title of Study
|
Evaluation of Clinical efficacy of Zandu Abhayarishta in the Management of Arsha (Hemorrhoids) with/without Associated Symptoms |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| N/A |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DRSANJAY SRIVASTAVA |
| Designation |
Associate Professor |
| Affiliation |
DR.S.R. RAJASTHAN AYURVED UNIVERSITY JODHPUR |
| Address |
Room No.162, Bharadwaj Bhawan, PGIA, DSRRAU, Jodhpur
RAJASTHAN
India
Jodhpur
RAJASTHAN
342037
India |
| Phone |
09414410383 |
| Fax |
|
| Email |
sanjayphyayu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DRSANJAY SRIVASTAVA |
| Designation |
Associate Professor |
| Affiliation |
DR.S.R. RAJASTHAN AYURVED UNIVERSITY JODHPUR |
| Address |
Room No.162, Bharadwaj Bhawan, PGIA, DSRRAU, Jodhpur
RAJASTHAN
India
RAJASTHAN
342037
India |
| Phone |
09414410383 |
| Fax |
|
| Email |
sanjayphyayu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DRSANJAY SRIVASTAVA |
| Designation |
Associate Professor |
| Affiliation |
DR.S.R. RAJASTHAN AYURVED UNIVERSITY JODHPUR |
| Address |
Room No.162, Bharadwaj Bhawan, PGIA, DSRRAU, Jodhpur
RAJASTHAN
India
RAJASTHAN
342037
India |
| Phone |
09414410383 |
| Fax |
|
| Email |
sanjayphyayu@gmail.com |
|
|
Source of Monetary or Material Support
|
| R&D Healthcare Division
Emami Ltd,
13 BT Road, Belgharia, Kolkata – 700056
Ph. No 91-033 6622317 |
|
|
Primary Sponsor
|
| Name |
Healthcare Division Emami Ltd |
| Address |
Sr. Manager, Medical Research
R&D Healthcare Division
Emami Ltd,
13 BT Road, Belgharia, Kolkata – 700056
Ph. No 91-033 66223176 |
| 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 |
| DrSanjay Srivastava |
Sanjeevani Ayurveda Hospital,DSRRAU |
OPD Block, ROOM NO,14
Jodhpur RAJASTHAN
Jodhpur
RAJASTHAN |
09414410383
sanjayphyayu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee - PGIA Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K928||Other specified diseases of the digestive system. Ayurveda Condition: ARSAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Haritaki, Reference: Bhavprakash Nighantu, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 650(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: with Abhayarishta), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: ABHAYARISHTA, Reference: Bharat Bhaishajya Ratnakar, Route: Oral, Dosage Form: Arishta, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: water), Additional Information: NIL | | 3 | Comparator Arm | Drug | Classical | | (1) Medicine Name: ABHAYARISHTA, Reference: Bharat Bhaishajya Ratnakar, Route: Oral, Dosage Form: Arishta, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: with lukewarm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients suffering from following minimum 3 symptoms from category A and B of symptoms associated with Arsha will be selected for this study.
Category A:
1. Swelling (Sotha)
2. Bleeding /Fissure (Raktashrava/ Parikartika)
3. Perianal Pain (Shula)
4. Burning (Daha)
5. Itching/ irritation (kandu)
Category B:
6. Loss of appetite (Kshudhanash)
7. Distended abdomen (Anaha)
8. Flatulence (Adhmana)
9. Acidity (Amlodgar)
10. Kosthabadhata (Constipation)
|
|
| ExclusionCriteria |
| Details |
1.Patients suffering from 3rd /4th degree piles
2.Patients who develop secondary complication of
Colitis, intestinal obstruction etc.
3.Any other serious illness e.g., Hepatic/ renal
failure/severe anemia.
4.Known hypersensitivity or allergy to one or more
of the herbal ingredients
5.Other debilitating neurological or psychiatric
disorders
|
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in Haemorrhoidal Symptoms: Evaluate the decrease in severity of symptoms such as pain, bleeding, prolapse, and itching as assessed using a validated grading or symptom severity scale over the study period. |
45days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in Quality of Life (QoL): Assess changes in patient-reported QoL using a hemorrhoid-specific QoL questionnaire.
Reduction in Recurrence Rate: Measure the recurrence of hemorrhoidal symptoms within the follow-up period.
Improvement in Bowel Habits: Evaluate changes in stool consistency, frequency, and straining using a standardized bowel habit questionnaire.
Safety Assessment: Monitor adverse effects or tolerability issues with Zandu Abhayarishta and Haritaki.
Overall Treatment Satisfaction: Patient-reported satisfaction with the treatment modality, based on a Likert scale or similar metric. |
45 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
06/02/2025 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
· Arsha are swollen blood vessels of the Anus &lower rectum.1 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. However, it is mostly observed in elderly people and during pregnancy. Ayurveda the ancient science of life, has described it as anorectal disorders in very detailed manner.2“arivat pranan shrunati hinasti iti arshaha”. · Zandu Abhayarishta is a well-known Classical Ayurvedic product from Ayurvedic text “Bharat Bhaishajya Ratnakar”, being marketed in India from more than five decades for the management of the symptoms associated with piles, indigestion & constipation. Zandu Abhayarishta contains Haritaki, Vidanga, Madhuka, Draksha, Dhanyaka,Sunthi, Indravaruni, Trivrit along with other Ayurvedic ingredients which are well known to have analgesic, anti-inflammatory, wound healing and antimicrobial digestive, laxative properties. Keeping all these facts it is decided to study on “Evaluation of Clinical efficacy of Zandu Abhayarishta in the Management of Arsha (Hemorrhoids) with/without Associated Symptoms.”
|