| CTRI Number |
CTRI/2026/01/100539 [Registered on: 08/01/2026] Trial Registered Prospectively |
| Last Modified On: |
07/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Treating PCOS using Darchini |
|
Scientific Title of Study
|
Efficacy of three different forms of Darchini (Cinnamomum zeylanicum) in the management of Polycystic Ovarian Syndrome : A Randomized Single Blind Comparative Clinical trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ilma Nazim |
| Designation |
PG Scholar |
| Affiliation |
Ajmal Khan Tibbiya College and Hospital Aligarh Muslim University |
| Address |
Department of Niswan Wa Qabalat Ajmal Khan Tibbiya College and Hospital AMU Aligarh Uttar Pradesh
Aligarh
UTTAR PRADESH
202001
India |
| Phone |
8433009507 |
| Fax |
|
| Email |
ilmanazimaljafri111@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abiha Ahmad Khan |
| Designation |
Assistant Professor |
| Affiliation |
Ajmal Khan Tibbiya College and Hospital Aligarh Muslim University |
| Address |
Department of Niswan Wa Qabalat Ajmal Khan Tibbiya College and Hospital AMU Aligarh Uttar Pradesh
Aligarh
UTTAR PRADESH
202001
India |
| Phone |
9620551870 |
| Fax |
|
| Email |
abihaahmad89@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ilma Nazim |
| Designation |
PG Scholar |
| Affiliation |
Ajmal Khan Tibbiya College and Hospital Aligarh Muslim University |
| Address |
Department of Niswan Wa Qabalat Ajmal Khan Tibbiya College and Hospital AMU Aligarh Uttar Pradesh
Aligarh
UTTAR PRADESH
202001
India |
| Phone |
8433009507 |
| Fax |
|
| Email |
ilmanazimaljafri111@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Niswan Wa Qabalat, Ajmal Khan Tibbiya College and Hospital, Faculty of Unani Medicine, Aligarh Muslim University, Aligarh, Uttar Pradesh, India, 202001 |
|
|
Primary Sponsor
|
| Name |
Department of Niswan Wa Qabalat |
| Address |
Department of Niswan Wa Qabalat,Ajmal Khan Tibbiya College and Hospital, Faculty of Unani Medicine AMU, Aligarh, UP, India 202001 |
| 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 Abiha Ahmad Khan |
Ajmal Khan Tibbiya College and Hospital |
OPD no.4 and IPD of Gynae Ward, Department of Niswan Wa Qabalat, Ajmal Khan Tibbiya College and Hospital, Faculty of Unani Medicine, AMU
Aligarh
UTTAR PRADESH |
9620551870
abihaahmad89@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS 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 |
Darchini Oil |
0.67 ml once in a day in tablet form for two months |
| Intervention |
Darchini powder |
3gm Darchini powder in tablet form BD per day for two months |
| Intervention |
Hydroalcoholic extract of Darchini |
240mg tablet once in a day for two months |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
49.00 Year(s) |
| Gender |
Female |
| Details |
Married and Unmarried females in the reproductive age group (18-49 years)
Subjects fulfilling the Rotterdam Criteria for diagnosis of PCOS |
|
| ExclusionCriteria |
| Details |
Pregnancy and lactation
Patients on Oral Contraceptive pills, Insulin sensitizing drugs or Oral Hypoglycemic drugs within 60 days before enrollment
Patient with systematic diseases like Diabetes mellitus, HTN, Thyroid dysfunction and Malignancy |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Resumption of regular menstrual cycle
Amelioration of Polycystic ovaries on USG
Conception |
2 months with follow up after every 15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in BMI
Change in Waist to Hip ratio |
2 months with follow up after every 15 days |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
20/01/2026 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Polycystic ovarian syndrome or hyperandrogenic anovulation is most mentioned endocrinopathies among women of child bearing age. PCOS presents with hyperandrogenism, acne, alopecia, abnormal menstrual cycle, polycystic ovaries, infertility and hirsutism. The global prevalence of PCOS varies between 2.2 and 26% and in India percentage of PCOS is around 9 to 22% affecting 5 to 10% of reproductive age women and rising to 15% in those with infertility. It is the leading cause of anovulatory infertility, accounting for about 75% of cases. The syndrome is defined by presence of at least two of the following symptoms based on Rotterdam consensus criteria a) oligomenorrhoea/ anovulation b) clinical or biochemical signs of hyperandrogenism c) presence of polycystic ovaries on ultrasound. In Unani system of Medicine, the term PCOS has not been mentioned but its translation " Marz e Ikhyase Khusyaturrahem" has been done in Arabic. Unani physicians described this disease under amenorrhoea, obesity, phlegmatic disease and liver disorder. Unani concept of PCOS is mainly based on dominance of Khilte Balgam. Balgam e mayi is the abnormal form which is thinner in consistency and accumulates in sacs to form cysts. A review of Unani literature shows that Sue Mizaj e Barid leads to the menstrual abnormalities, oligomenorrhoea, amenorrhoea , hirsutism, obesity, acne, hoarseness of voice and uqr which are suggestive of PCOS. Scientific evaluation of Unani drugs is quite necessary due to unavailability of safe and effective drugs. Therefore, darchini arranged from Sri Lanka is selected to study its efficacy in PCOS. The present design will be single blind and randomized study at Ajmal Khan Tibbiya College and Hospital with a sample size of 40 patients in each group. The data will be analysed by using appropriate statistical tools and will be presented in the form of tables and graphs. |