| CTRI Number |
CTRI/2023/06/054286 [Registered on: 21/06/2023] Trial Registered Prospectively |
| Last Modified On: |
14/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Clinical Study to evaluate the Rakta Stambhana effect of Yavanyadi Churna & Nagkeshara Churna in the management of Raktasrava with special reference to Anal Bleed |
|
Scientific Title of Study
|
A Randomized Comparative Clinical Study to evaluate the Rakta Stambhana effect of Yavanyadi Churna & Nagkeshara Churna in the management of Raktasrava with special reference to Anal Bleed |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Saurabh Banjare |
| Designation |
PG Scholar Shalyatantra |
| Affiliation |
Basveshwar Verashaiva Vidyavardhaka Sangha Ayurved Medical College and Hospital, Bagalkot, Karnatka |
| Address |
Basveshwar Verashaiva Vidyavardhaka Sangha Ayurved Medical College and Hospital
Ward No 10
Shalyatantra OPD
Room No 10
Bagalkot
KARNATAKA
587101
India |
| Phone |
7879992813 |
| Fax |
|
| Email |
saurabhbanjare58@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pallavi A Hegde |
| Designation |
Professor |
| Affiliation |
BVVS Ayurved Medical College and Hospital, Bagalkot, Karnatka |
| Address |
BVVS Ayurved Medical College and Hospital
Ward no 10
Bagalkot
KARNATAKA
587101
India |
| Phone |
9448636321 |
| Fax |
|
| Email |
drpallaviah@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr M M Salimath |
| Designation |
Principal And Professor |
| Affiliation |
Basveshwar Verashaiva Vidyavardhaka Sangha Ayurved Medical College and Hospital, Bagalkot, Karnatka |
| Address |
Basveshwar Verashaiva Vidyavardhaka Sangha Ayurved Medical College and Hospital
Ward no 10
Principal cabin
Room No 2
Bagalkot
KARNATAKA
587101
India |
| Phone |
9845010950 |
| Fax |
|
| Email |
dr_mahantesh@yahoo.com |
|
|
Source of Monetary or Material Support
|
| BVVS Ayurved Medical College and Hospital |
|
|
Primary Sponsor
|
| Name |
BVVS Ayurved Medical College and Hospital |
| Address |
BVVS Ayurved Medical College and Hospital
Ward no 10 |
| Type of Sponsor |
Private medical college |
|
|
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 Saurabh Banjare |
BVVS Ayurved Medical College and Hospital |
Basveshwar Verashaiva Vidyavardhaka Sangha Ayurved Hospital
Ward no 10
Department of Shalyatantra
Room no 10
Bagalkot
KARNATAKA |
7879992813
saurabhbanjare58@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC BVVS Ayurved Medical College and Hospital, Bagalkot, Karnataka |
Approved |
|
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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: RAKTASRAVAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Yavanyadi Churna, Reference: Astangahridayam Chikitsa sthan, Route: Oral, Dosage Form: Churna/ Powder, Dose: 4(g), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 10 Days, anupAna/sahapAna: Yes(details: Luke warm water), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Nagakeshara Churna, Reference: Bhavaprakash Nighantu, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1(g), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 10 Days, anupAna/sahapAna: Yes(details: Luke warm water), Additional Information: - |
|
|
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Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Raktasrava (Bleed per rectum)
Daha (Burning sensation)
Shoola (Pain)
Avagadha pureesha (Hard stool)
|
|
| ExclusionCriteria |
| Details |
Patients suffering from Bleeding Disorders like- Anal polyp
Prolapsed rectum
Ulcerative colitis
Crohn’s disease
Carcinoma of rectum and anus
Infectious disease like RVD, HBsAg
Pregnant and Lactating women |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Rakta Stambhana effect of Yavanyadi Churna in the management of Raktasrava. |
10 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Rakta Stambhana effect of Nagakeshara Churna in the management of Raktasrava. |
10 Days |
| To Compare the Rakta Stambhana effect of Yavanyadi Churna & Nagkeshara Churna in the management of Raktasrava. |
10 Days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
24/06/2023 |
| 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
|
Bleeding per rectum is the commonest but alarming symptom of all the anorectal complaints of the patients. Acute overt Lower Gastro-Intestinal Bleed (LGIB) accounts for approximately 20% of all cases of GI Bleed1. Rectal bleeding has a prevalence of 14% to 19% in adults1. 44.9% of general practitioner referrals for colonoscopy presenting rectal bleed found serious abnormalities. Since rectal bleeding is a cardinal symptom of many colorectal diseases including colorectal cancers, haemorrhoids, fissure in ano, fistula in ano, etc1. 1st and 2nd degree haemorrhoids present with bleeding- splash in the pan (bright red in colour), and mass per anum (2nd degree haemorrhoids)2. while Acute fissure-in-ano features as bleeding (dropwise or streak along the stool), pain and constipation3. In classics Pittaja and Raktaja varieties of Gudagata Rogas having bleeding per rectum as the commonest symptom. Gudagata Raktasrava is mainly noted in Pittaja Arsha and Raktaja Arsha associated with Daha and Avagadha Pureesha4, while Parikartika is also due to Pittaprakopa presenting with Tivarashoola and Raktasrava from Gudpradesha5. In classics we get various treatment modalities for Gudagata Vikara associated with Raktasrava. Acharya Vagbhata has mentioned about Yavanyadi Churna, which is indicated in the management of Atishonita Pravrutti (Profuse Bleed)6, whereas Nagakeshara Churna is said to be act as Shonita Sthapana in Bhavaprakash Nighantu7. Yavanyadi Churna ingredients are Yavani, Indrayava, Patha, Bilwa, Shunthi, Rasanjana and all are having properties like Katu, Tikta, Kashaya Rasa which leads to Kaphashamana and Raktasthambhana, Ushna Veerya and Katu Vipaka leads to Kaphashamana, Aamapachana and Agnideepana8. Nagakeshara Churna having properties of Kashaya Tikta Rasa, Laghu Ruksha Guna, Katu Vipaka, Sheetoshna Veerya and works as Kaphapittashamaka which is said to be act as Shonita Sthapana7. As both Yavanyadi Churna and Nagakeshara Churna are indicated for Shonita Sthapana, Hence the present study in undertaken to evaluate the Rakta Stambhana effect of Yavanyadi Churna and Nagakeshara Churna in the management of Anal Bleed. |