| CTRI Number |
CTRI/2025/05/087647 [Registered on: 26/05/2025] Trial Registered Prospectively |
| Last Modified On: |
29/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Efficacy of Sphatika Guda Varti in the Management of Raktaarshas with special reference to first and second degree bleeding Hemorrhoids. |
|
Scientific Title of Study
|
A randomized open label controlled clinical study to evaluate the efficacy of Sphatika Guda Varti in the management of Raktaarshas with special reference to first and second degree bleeding Hemorrhoids. |
| 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 Sowjanya K B |
| Designation |
PG Scholar |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research |
| Address |
Department of PG studies in Shalya Tantra,Sri Sri College of Ayurvedic Science and Research,21st km,Kanakapura road,Udayapura post,Bengaluru-560082
Bangalore
KARNATAKA
560082
India |
| Phone |
9108586945 |
| Fax |
|
| Email |
sowjukb@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dhyan Surendranath |
| Designation |
Associate Professor |
| Affiliation |
Sri Sri College Of Ayurvedic Science and Research |
| Address |
Department of PG studies in Shalya Tantra,Sri Sri College Of Ayurvedic Science and Research,21st KM,Kanakapura road,Udayapura Post,Bengaluru-560082
Bangalore
KARNATAKA
560082
India |
| Phone |
9164353330 |
| Fax |
|
| Email |
dhyan88@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sowjanya K B |
| Designation |
PG Scholar |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research |
| Address |
Department of PG Studies in Shalya Tantra,Sri Sri College of Ayurvedic Science and Research,21st KM,Kanakapura road,Udayapura Post,Bengaluru-560082
Bangalore
KARNATAKA
560082
India |
| Phone |
9108586945 |
| Fax |
|
| Email |
sowjukb@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Sri College Of Ayurvedic Science and Research Hospital,21st KM,Kanakapura road,Udayapura post,Bengaluru-560082 |
|
|
Primary Sponsor
|
| Name |
Dr Sowjanya K B |
| Address |
Department Of PG Studies in Shalya Tantra,Sri Sri College Of Ayurvedic Science and Research,21st KM,Kanakapura road,Udayapura Post,Bengaluru-560082 |
| 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 Sowjanya K B |
Sri Sri College Of Ayurvedic Science and Research Hospital |
Department of PG Studies in Shalya Tantra,Sri Sri College of Ayurvedic Science and Research,21st KM,Kanakapura road,Udayapura Post,Bengaluru-560082
Bangalore
KARNATAKA |
9108586945
sowjukb@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Sri Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K640||First degree hemorrhoids. Ayurveda Condition: ARSAH, (2) 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 | Classical | | (1) Medicine Name: SPHATIKA, Reference: RASATARANGINI, Route: Rectal, Dosage Form: Varti/ Suppository, Dose: 2(g), Frequency: od, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 7 Days, Reference: No, Route: -, Dosage Form: Varti/ Suppository, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: SPHATIKA JALA, Reference: RASATARANGINI, Route: Rectal, Dosage Form: Kwatha/ Kashaya, Dose: 30(ml), Frequency: od, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 7 Days, Reference: No, Route: -, Dosage Form: Kwatha/ Kashaya, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects aged between 21–70 years, irrespective of gender, religion, occupation, socio-economic status and educational status.
2.Subjects who fulfills the diagnostic criteria of 1st and 2nd degree bleeding internal hemorrhoids.
3.Subjects willing to give consent.
|
|
| ExclusionCriteria |
| Details |
1.Hemorrhoids associated with Rectal prolapse.
2.Thrombosed pile mass.
3.Hemorrhoids associated with Fistula-in-Ano.
4.Subject with other systemic illness like Tuberculosis, Ulcerative colitis and Crohn’s disease.
5.Subjects With HIV, HBsAg.
6.Subjects with Autoimmune diseases .
7.Subjects who are Pregnant and lactating.
8.Subjects not willing to give consent.
9.Subjects who are under antiplatelet and anticoagulant medication.
|
|
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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 |
| Significant change in the Rakta Srava |
1st,3rd,5th,7th Day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduced size of internal hemorrhoidal masses & Vibandha |
7th & 14th Day. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
30/05/2025 |
| 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="0"
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
|
This study have been taken up to evaluate the efficacy of Sphatika Guda Varti in the management of Rakta Arshas with special reference to 1st and 2nd degree bleeding Hemorrhoids.
Comparison with Sphatika Jala Per Rectal Instillation.
HYPOTHESIS
1.NULL HYPOTHESIS:
H0: There is no significant difference between the efficacy of Sphatika Guda Varti and Sphatika Jala Per Rectal instillation in the management of Rakta Arshas with special reference to 1st and 2nd degree bleeding hemorrhoids.
2.ALTERNATE HYPOTHESIS:
H1: The efficacy of Sphatika Guda Varti is better than Sphatika Jala Per Rectal instillation in the management of Rakta Arshas with special reference to 1st and 2nd degree bleeding hemorrhoids.
H2: The efficacy of Sphatika Jala Per Rectal instillation is better than Sphatika Guda Varti in the management of Rakta Arshas with special reference to 1st and 2nd degree bleeding hemorrhoids.
|