| CTRI Number |
CTRI/2021/04/032652 [Registered on: 08/04/2021] Trial Registered Prospectively |
| Last Modified On: |
07/04/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Efficacy of Madhukadi Yoga and Madhukadi Tail in Management of Asrigdar. |
|
Scientific Title of Study
|
A Clinical Study to Evaluate the Efficacy of Madhukadi yoga and Madhukadi Tailam Matra Vasti in Asrigdara |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrSeema Shukla |
| Designation |
Head Of Department, Prasuti tantra evum Stree Roga |
| Affiliation |
RGGPG Ayurvedic College and Hospital |
| Address |
RGGPG Ayurvedic College and Hospital, Room no. 804/210, Paprola, Kangra,
RGGPG Ayurvedic College and Hospital, Paprola, Kangra
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418008833 |
| Fax |
|
| Email |
drseemanil@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrSeema Shukla |
| Designation |
Head Of Department, Prasuti tantra evum Stree Roga |
| Affiliation |
RGGPG Ayurvedic College and Hospital |
| Address |
RGGPG Ayurvedic College and Hospital, room no. 804/210 Paprola, Kangra
RGGPG Ayurvedic College and Hospital, Paprola, Kangra
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418008833 |
| Fax |
|
| Email |
drseemanil@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrLaxmita Gaiju |
| Designation |
PG Scholar |
| Affiliation |
RGGPG Ayurvedic College and Hospital |
| Address |
RGGPG Ayurvedic College and Hospital, room no.804, Paprola, Kangra
RGGPG Ayurvedic College and Hospital, Paprola, Kangra
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
6230028525 |
| Fax |
|
| Email |
gaijuluxmita11@gmail.com |
|
|
Source of Monetary or Material Support
|
| Charak Pharmacy, RGGPG Ayurvedic College and Hospital, ISM Jogindernagar |
|
|
Primary Sponsor
|
| Name |
Principal RGGPG Ayurvedic College and Hospital Paprola Kangra |
| Address |
RGGPG Ayurvedic College and Hospital, Paprola, Kangra |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| HOD Department of Prasuti Tantra Evum Stree Roga |
RGGPG Ayurvedic College and Hospital, Paprola, Kangra, H.P. |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrSeema Shukla |
RGGPG Ayurvedic College and Hospital |
OPD and IPD of Department of Prasuti Tantra evum Stree Roga, RGGPG Ayurvedic College and Hospita, Paprola, Kangra
Kangra
HIMACHAL PRADESH |
9418008833
drseemanil@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (Human), RGGPG Ayurvedic College and Hospital, Paprola |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N921||Excessive and frequent menstruation with irregular cycle. Ayurveda Condition: Asrigdara, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Madhukadi Tailam |
60ml of Madhukadi Tailam per rectum for 8 days after clearance of Menses for 3 consecutive cycles |
| Intervention |
Madhukadi Yoga |
3gm of Madhukadi Yoga orally twice daily for 3 consecutive cycles
|
| Comparator Agent |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
i. Patients willing for the trial.
ii. Patients between the age group of 35 – 50 years.
iii. Patients, with either one or all symptoms of Asrigdara like Ritou Atipravitti (excessive bleeding during menstruation), Anritou pravritti (intermenstrual bleeding), Deergha Pravritti (prolonged bleeding).
|
|
| ExclusionCriteria |
| Details |
i. Patient not willing for trial.
ii. Patients with uterine and pelvic pathology like big fibroid (>5cm), Ca cervix, cervical polyp etc.
iii. Patients having bleeding sites other than uterus.
iv. Bleeding due to coagulation disorders.
v. Women using OCPs.
vi. Medical illnesses.
vii. If condition of patients deteriorated during trial they shall be discontinued from trial.
|
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Fulfillment of subjective and objective criterias |
90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| General reproductive well being of the individual |
90 days (approx.) |
|
|
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)
|
15/04/2021 |
| 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
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Research Report will be soon published after the completion of trial. 30 patients fulfilling the inclusion and exclusion criterias will be randomly selected from the OPD and IPD of Department of Prasuti Tantra evum Stree Roga, RGGPG Ayurvedic College and Hospital, Paprola. Patients will be divided randomly into 2 groups; Group I and Group II each with 15 patients. Group I will be given oral preparation of Madhukadi Yoga and Matra vasti of Madhukadi Tailam per rectum while Group II will be Oral preparation of Madhukadi Yoga only. Result will be assessed on the basis of subjective and objec tive assessment criterias. |