| CTRI Number |
CTRI/2024/07/069778 [Registered on: 01/07/2024] Trial Registered Prospectively |
| Last Modified On: |
27/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical study to evaluate the efficacy of Kalajaji taila orally in Artava kshaya, Oligohypomenorrhea for a period of 3 consecutive menstrual cycles |
|
Scientific Title of Study
|
An open label double arm randomized controlled clinical study on the efficacy of Kalajaji taila orally in Artava Kshaya, Oligohypomenorrhea |
| 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 Pratheeksha M |
| Designation |
PG Scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Anchepalya, Bengaluru |
| Address |
Department of Prasuti tantra and Stri roga OPD No. 4,5,6,24,29 Sri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Anchepalya, Bengaluru
Bangalore
KARNATAKA
560074
India |
| Phone |
9449991244 |
| Fax |
|
| Email |
pratheekshanisarga@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anusha M |
| Designation |
Associate Professor |
| Affiliation |
Sri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Anchepalya, Bengaluru |
| Address |
Department of Prasuti tantra and Stri roga OPD No.5 Sri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Anchepalya, Bengaluru
Bangalore
KARNATAKA
560074
India |
| Phone |
8105777424 |
| Fax |
|
| Email |
dranusham@sdmayurbangalore.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pratheeksha M |
| Designation |
PG Scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Anchepalya, Bengaluru |
| Address |
Department Of Prasuti Tantra and Stri Roga OPD No. 4,5,6,24,29 Sri Dharmasthala Manjunatheshwara Institute Of Ayurveda And Hospital, Anchepalya, Bengaluru
Bangalore
KARNATAKA
560074
India |
| Phone |
9449991244 |
| Fax |
|
| Email |
pratheekshanisarga@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Prasuti Tantra And Stri Roga Opd No. 4,5,6,24,29 Sri Dharmasthala Manjunatheshwara Institute Of Ayurveda And Hospital, Anchepalya, Bengaluru- 560074, Karnataka, India. |
|
|
Primary Sponsor
|
| Name |
Dr Pratheeksha M |
| Address |
Department Of Prasuti Tantra and Stri Roga OPD No. 4,5,6,24,29 Sri Dharmasthala Manjunatheshwara Institute Of Ayurveda And Hospital, Anchepalya, Bengaluru |
| 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 Pratheeksha M |
Sri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Anchepalya, Bengaluru |
Department Of Prasuti Tantra and Stri Roga OPD No. 4,5,6,24,29 Sri Dharmasthala Manjunatheshwara Institute Of Ayurveda And Hospital, Anchepalya, Bengaluru
Bangalore
KARNATAKA |
9449991244
pratheekshanisarga@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE SRI DHARMASTHALA MANJUNATHESHWARA INSTITUTE OF AYURVEDA AND HOSPITAL |
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: KALAJAJI TAILA, Reference: SIDDHA BHESHAJA MANIMALA, Route: Oral, Dosage Form: Taila, Dose: 10(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: USHNA JALA), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: HINGWADI TAILA, Reference: BHAISHAJYA RATNAVALI, Route: Oral, Dosage Form: Taila, Dose: 10(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: USHNA JALA), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1. PATIENTS WILLING TO BE PART OF TREATMENT OF ARTAVAKSHAYA, OLIGOHYPOMENORRHEA.
2. PATIENTS FULFILLING THE CARDINAL SYMPTOMS OF ARTAVAKSHAYA, OLIGOHYPOMENORRHEA.
3. WOMEN OF AGE GROUP 18- 40 YEARS.
|
|
| ExclusionCriteria |
| Details |
1. MARKED ANEMIA (HB LESSER THAN 7G).
2. SUBJECTS ON ORAL CONTRACEPTIVE PILLS, INTRA UTERINE CONTRACEPTIVE DEVICES.
3. SUBJECTS SUFFERING FROM ANY SYSTEMIC ILLNESS SUCH AS HYPERTENSION AND DIABETES MELLITUS.
4. LACTATING WOMEN.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Significant reduction in signs and symptoms of Artava Kshaya, oligohypomenorrhea based on grading. |
Baseline, 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improved quality of life & prevent recurrence in patients diagnosed with Artava Kshaya, oligohypomenorrhea. |
Baseline, 3 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
08/07/2024 |
| Date of Study Completion (India) |
31/07/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
An
open label double arm randomized controlled clinical study on the efficacy of
Kalajaji taila orally on Artava Kshaya, Oligohypomenorrhea in females of age
group 18-40 years for a period of 3 consecutive menstrual cycles. During the
study period 40 women will be recruited and divided into two groups, group
A(trial drug) and group B(control drug) with 20 women in each group. Group A
will receive Kalajaji taila and group B will receive Hingwadi taila in the
dosage of 10ml before food in the morning for 2 consecutive menstrual cycles
except on the days of menses followed by one follow up menstrual cycle.
Clinical assessment will be done after each menstrual cycle for 3 cycles and
statistical analysis will be done after every cycle. |