| CTRI Number |
CTRI/2024/04/065052 [Registered on: 02/04/2024] Trial Registered Prospectively |
| Last Modified On: |
01/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Randomised observational study |
| Study Design |
Other |
|
Public Title of Study
|
Effect of dry cupping in PCOD |
|
Scientific Title of Study
|
Incidence of PCOD (marz akyas khusiyat ur rahem) in individuals of different temperaments and efficacy of dry cupping (hijama bila shurt) in it. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Naushaba Parveen |
| Designation |
PG scholar |
| Affiliation |
Govt. Nizamia tibbi college and general hospital charminar Hyderabad |
| Address |
Pg Department of kulliyat e tibb Govt. Nizamia tibbi college and general hospital charminar Hyderabad
Hyderabad
TELANGANA
500002
India |
| Phone |
6263644233 |
| Fax |
|
| Email |
naushabaansari416@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mohd Yousufuddin |
| Designation |
Guide and Hod of PG department of kulliyat |
| Affiliation |
Govt. Nizamia tibbi college and general hospital charminar Hyderabad |
| Address |
OP-6, PG Department of kulliyat e tibb,Govt. Nizamia tibbi college and general hospital charminar Hyderabad
Hyderabad
TELANGANA
500002
India |
| Phone |
9912904786 |
| Fax |
|
| Email |
yousufmohd96@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Naushaba Parveen |
| Designation |
PG Scholar |
| Affiliation |
Govt. Nizamia tibbi college and general hospital charminar Hyderabad |
| Address |
PG Department of kulliyat e tibb Govt. Nizamia tibbi college and general hospital charminar Hyderabad
Hyderabad
TELANGANA
500002
India |
| Phone |
6263644233 |
| Fax |
|
| Email |
naushabaansari416@gmail.com |
|
|
Source of Monetary or Material Support
|
| Govt. Nizamia tibbi college and general hospital charminar Hyderabad Telangana India 500002 |
|
|
Primary Sponsor
|
| Name |
Govt Nizamia tibbi college and general hospital |
| Address |
Govt.Nizamia tibbi college and general hospital,PG Department of kulliyat e tibb,charminar Hyderabad,Telangana,India,500002 |
| Type of Sponsor |
Government 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 Naushaba Parveen |
Govt Nizamia tibbi college and general hospital charminar Hyderabad Telangana |
OPD NO. 06 Pg Department of kulliyat e tibb Govt Nizamia tibbi college and general hospital charminar
Hyderabad
TELANGANA |
6263644233
naushabaansari416@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E282||Polycystic ovarian syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Patient attending OP of GNTC
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluating dry Cupping therapy in the management of PCOD in individuals of different temperament |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Conclude/Prove The Statistical Analysis of Incidence of PCOD (Marz Akyas Khusiyat ur rahem) in individuals of different temperament and efficiency of dry cupping (Hijama bila shurt) in it |
4 weeks |
|
|
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)
|
11/04/2024 |
| 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="4"
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
|
PCOD is a heterogeneous endocrinopathy in a woman of reproductive age group with the ovarian expression of various metabolic disturbances and wide spectrum of clinical features such as obesity manstrual abnormalities and hyper androgenism it is also becoming a common problem among adolescence developing soon after puberty among infertile women about 20% is attributed to an ovulation caused by PCOS Currently available treatment is hormonal therapy and insulin sensitizing agents used in PCOS. Matformine is the most widely used drug in PCOS is often poorly tolerated because of its GIT side effects and hormonal therapy has got its own complications like Venus thromboembolism, stroke, breast cancer, and ovarian cancer due to its long-term usage One particular form of regimental therapies is therapeutic cupping which is a natural holistic preventive and curative regimen this therapy is one of the oldest and most effective method of releasing toxins from the body tissues and organs there is a two types of cupping wet cupping and dry cupping. Dry Cupping in this type of cupping cups are applied on a skin of different areas of the body without incision and vacuum is created by suction in increases the blood flow in the area Dry capping works on the principle of when there is increase in coldness of any organ then it should be provided with the hotness for which cups are placed and sucked which result in enhancement of blood circulation which provides the hotness to the organ it correct the abnormal cold temperament. |