| CTRI Number |
CTRI/2022/05/042583 [Registered on: 17/05/2022] Trial Registered Prospectively |
| Last Modified On: |
10/05/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical trial of gudahingvadi yoga in oligohypomenorrhoea |
|
Scientific Title of Study
|
A single arm clinical trial of gudahingvadi yoga orally in artavakshaya w.s.r. to oligohypomenorrhoea |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR SAPANA RAGHUNATH KAMBLE |
| Designation |
PG Scholar |
| Affiliation |
Yashwant Ayurvedic College |
| Address |
Yashwant Ayurvedic College, post Graduate Training & research center, Kodoli,tal- Panhala. dist-Kolhapur
Near Ambabai Mandir
Kodoli Kolhapur
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
7219042998 |
| Fax |
|
| Email |
dr.sapanakamble10@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR VISHALA TURLAPATI |
| Designation |
Professor HOD |
| Affiliation |
Yashwant Ayurvedic College |
| Address |
Opd no 8 Yashwant Ayurvedic College, post Graduate Training & research center, Kodoli,tal- Panhala. dist-Kolhapur
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9960217429 |
| Fax |
|
| Email |
vishalaturlapati@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SAPANA RAGHUNATH KAMBLE |
| Designation |
PG Scholar |
| Affiliation |
Yashwant Ayurvedic College |
| Address |
Yashwant Ayurvedic College, post Graduate Training & research center, Kodoli,tal- Panhala. dist-Kolhapur
Near Ambabai Mandir
Kodoli Kolhapur
MAHARASHTRA
416114
India |
| Phone |
7219042998 |
| Fax |
|
| Email |
dr.sapanakamble10@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr SAPANA RAGHUNATH KAMBLE |
| Address |
Yashwant Charitable hospital, kodoli |
| 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 SAPANA RAGHUNATH KAMBLE |
Yashwant Ayurvedic hospital |
Opd no 8, Yashwant Ayurvedic College, Kodoli, tal-Panhala
Kolhapur
MAHARASHTRA |
7219042989
dr.sapanakamble10@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:N915||Oligomenorrhea, unspecified. Ayurveda Condition: ARTAVAKSHAYAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Gudahingvadi yog, Reference: Sarth Rasaratnakara, Route: Oral, Dosage Form: Churna/ Powder, Dose: 4(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -Til Kwatha 20ml), Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1.Female patients irrespective of caste , income group and any occupation will be selected
2.Oligohypomenorrhoa
3.intermenstrual duration more than 35 days and menstrual bleeding flow less than 2 days.
4.BMI – 18-30
5.Age group 18-35 yrs(married , unmarried , nulliparous,parous, multiparous )
6.The duration of menses flow is less than 2 days and interval between two cycles exceeds than 35 days. |
|
| ExclusionCriteria |
| Details |
K/H/O malignancy , cervical erosion , polyp , adenomyosis , pelvic endometriosis , tubo ovarian mass ,
Pelvic Inflammatory Infection
Premature Ovarian Failure
Patients undergoing treatment for any other serious illness.
Those having Intermentstrual bleeding
K/c/o CA cervix and endometrial CA
Severe Anaemia (HB < 7%)
Lactating woman
Woman having IUCD
PCOS metabolic syndrome |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Decrease the symptoms
using Gudahingvadi Yog in Artavakshaya W.S.R. to Oligohypomenorrhoea as Pictorial Blood Assessment Chart |
4 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To achieve improvement in Artavakshaya condition i.e. decreasing intermenstrual duration & increasing the quality of menstrual bleeding
To assess the improvement by comparing the changes in Pictorial blood Chart as & ultrasonography before and after treatment
To achieve the improvement in a span of 120 days
To study in detail the Nidana Samprapti of Artavakshaya and etiopathology of oligohypomenorrhoea |
120 days |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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 2 |
|
Date of First Enrollment (India)
|
21/05/2022 |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
CLINICAL TRIAL OF GUDAHINGVADI YOGA ORALLY
IN ARTAVAKSHAYA W.S.R. TO OLIGOHYPOMENORRHOEA. Study will be held at OPD of Striroga Prasuti Tantra Department of Yashwant Hospital Kodoli |