| CTRI Number |
CTRI/2025/09/094785 [Registered on: 15/09/2025] Trial Registered Prospectively |
| Last Modified On: |
11/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study on the Effect of Guggulu Sutra Treatment in People with Pilonidal Sinus (a Type of Boil or Swelling Near the Tailbone) |
|
Scientific Title of Study
|
EFFECT OF GUGGULU SUTRA IN PILONIDAL SINUS |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dana Muhammed |
| Designation |
PG Scholar |
| Affiliation |
Govt Ayurveda College, Kannur |
| Address |
Department of Salyatanthra
Govt Ayurveda College,
Pariyaram
Kannur
Kannur
KERALA
670503
India |
| Phone |
8281706537 |
| Fax |
|
| Email |
drdaana@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K Gangadharan |
| Designation |
Professor & Head |
| Affiliation |
Govt Ayurveda College, Kannur |
| Address |
Department of Salyatanthra
Govt Ayurveda College, Pariyaram
Kannur
Kannur
KERALA
670503
India |
| Phone |
9496777170 |
| Fax |
|
| Email |
drkganga@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dana Muhammed |
| Designation |
PG Scholar |
| Affiliation |
Govt Ayurveda College, Kannur |
| Address |
Department of Salyatanthra
Govt Ayurveda College, Pariyaram
Kannur
Kannur
KERALA
670503
India |
| Phone |
8281706537 |
| Fax |
|
| Email |
drdaana@gmail.com |
|
|
Source of Monetary or Material Support
|
| GOVT AYURVEDA COLLEGE HOSPITAL PAIYARAM KANNUR, KERALA INDIA PIN 670503 |
|
|
Primary Sponsor
|
| Name |
Dana Muhammed |
| Address |
PG Scholar
Govt Ayurveda College, Kannur |
| 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 K Gangadharan |
Govt Ayurveda College Hospital, Pariyaram, Kannur |
OP No 9, Department of Salyatanthra,
Kannur
KERALA |
9496777170
drkganga@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:L050||Pilonidal cyst and sinus with abscess. Ayurveda Condition: NADIVRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | kShArasUtra, क्षारसूत्र | (Procedure Reference: Susrutha Samhita, Nadivruna Chikitsa, Procedure details: METHOD OF PREPARATION OF GUGGULU SUTRA
The linen barbour thread no. 20 will be autoclaved & will be mounted in hanger. Initially, seven coating of Guggulu extract will be done on the thread. After each coating the hanger will be dried in the Ksharasutra cabinet. Finally, four coatings will be done with Guggulu extract mixed with Haridra choorna. After drying the 11
th coating, the sutra will be cut into pieces of 10 inches & each piece will be kept in air tight glass tube.
PROCEDURE FOR APPLICATION OF GUGGULU SUTRA:
i. The participant will be comfortably laid in the prone position.
ii. A malleable copper probe will be introduced into the opening & it will be carefully
introduced along the direction of track.
iii. The probe will be brought out through the incised blind end.
iv. Sutra of suitable length will be passed through the eye of the probe & the probe will
be pulled out to position the thread in the track.
v. Then the two ends of the thread will be tied.)
|
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Diagnosis will be made on the basis of clinical examination
2. Pilonidal sinus in sacrococcygeal region diagnosed by clinical examination.
3. Participants within the age group 15-50 years.
4. Participants with written informed consent or assent.
5. Participants will be selected irrespective of gender, religion and economic status |
|
| ExclusionCriteria |
| Details |
1. Known cases of Tuberculosis.
2. Participants with uncontrolled Diabetes mellitus and Hypertension.
3. Participants positive for HIV, Hepatitis and any venereal disease.
4. Known cases of Bleeding disorder.
5. Pregnancy and lactation. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Unit Cutting Time
|
7
th,14th, 21st,28th,35th,42nd,49th, 56th, 63rd
, and
70th days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Discharge |
7
th,14th, 21st,28th,35th,42nd,49th, 56th, 63rd
, and
70th days |
| Healing effect |
7
th,14th, 21st,28th,35th,42nd,49th, 56th, 63rd
, and
70th days |
| Inflammation |
7
th,14th, 21st,28th,35th,42nd,49th, |
| Pain |
7
th,14th, 21st,28th,35th,42nd,49th, 56th, 63rd
, and
70th days |
|
|
Target Sample Size
|
Total Sample Size="14"
Sample Size from India="14"
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)
|
25/09/2025 |
| 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="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
In the present study 14 participants, diagnosed with pilonidal sinus will be selected from OPD and IPD of Shalyatantra department of Govt Ayurveda College Hospital, Kannur based on inclusion criteria. Guggulu sutra will be prepared by initial seven times smearing of extract of Guggulu on linen barbour thread no. 20 followed by four coatings of Guggulu extract mixed with Haridra choorna. Application of the Sutra will be done after baseline analysis of the participants. Assessment of participants and changing of sutra will be done on every 7th day for 70 days or until the thread cut through. Assessment will be done based on objective parameters such as unit cutting time, healing effect assessed by measuring length of resultant wound, discharge, inflammation and pain as objective parameter, on the basis of scoring system prepared by Paul O Madson and Peter. Collected data will be statistically analysed and the study will be concluded. |